ARROW RADIAL ARTERY CATHETERIZATION SET— 510(k) K810675

Clearance details

Applicant

Arrow Intl., Inc.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

1981-03-12

Decision date

1981-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 005202009-12-18
• K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES2007-10-10
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• K071111 — NON-ABSORBABLE SILK SUTURE2007-07-17

Death

298

Injury

4,385

Malfunction

7,203

Other

5

Total

11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2397-2026 — Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1Class I·Ongoing·ARROW INTERNATIONAL, LLC·20260421
• Z-3299-2024 — Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.Class II·Ongoing·ARROW INTERNATIONAL Inc.·20240726
• Z-0844-2020 — Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.Class II·Ongoing·Arrow International Inc·20191212
• Z-1968-2018 — Radial Arterial Access Kit; Product Code: ASK-04001-BID2Class II·Terminated·Arrow International Inc·20180411
• Z-1969-2018 — Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1Class II·Terminated·Arrow International Inc·20180411
• Z-1970-2018 — Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1Class II·Terminated·Arrow International Inc·20180411
• Z-1971-2018 — Arterial Catheterization Kit; Product Codes: ASK-04020-DHClass II·Terminated·Arrow International Inc·20180411
• Z-1972-2018 — Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHMClass II·Terminated·Arrow International Inc·20180411
• Z-2019-2018 — Arterial Catheterization Kit; Product Code:NA-04550-1AClass II·Terminated·Arrow International Inc·20180411
• Z-1330-2018 — (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1AClass II·Terminated·Arrow International Inc·20171222
• Z-1281-2018 — Radial Artery Catheterization Kit; Model: AK-04018Class II·Terminated·Arrow International Inc·20171026
• Z-1282-2018 — Radial Artery Catheterization Kit; Model: AK-04020Class II·Terminated·Arrow International Inc·20171026
• Z-1283-2018 — Radial Artery Catheterization Kit; Model: AK-04020-CClass II·Terminated·Arrow International Inc·20171026
• Z-1284-2018 — Radial Artery Catheterization Kit; Model: AK-04120Class II·Terminated·Arrow International Inc·20171026
• Z-1285-2018 — Radial Artery Catheterization Kit; Model: AK-04122Class II·Terminated·Arrow International Inc·20171026
• Z-1286-2018 — Radial Artery Catheterization Kit; Model: AK-04220Class II·Terminated·Arrow International Inc·20171026
• Z-0486-2018 — Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.Class II·Terminated·Arrow International Inc·20170710
• Z-2327-2017 — Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vesselsClass II·Terminated·Arrow International Inc·20170509
• Z-2740-2016 — Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.Class II·Terminated·Arrow International Inc·20160808
• Z-2741-2016 — Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.Class II·Terminated·Arrow International Inc·20160808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810675.