ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840— 510(k) K021462

Clearance details

Applicant

Arrow Intl., Inc.

Product code

Code DSP

Device class

Class 2

Regulation

21 CFR 870.3535

Advisory panel

Cardiovascular

Date received

2002-05-07

Decision date

2002-06-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Everett, MA, US

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• K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2020-05-27
• K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
• K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

• K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-455042010-08-27
• K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 005202009-12-18
• K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES2007-10-10
• K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT2007-09-26
• K071111 — NON-ABSORBABLE SILK SUTURE2007-07-17

Death

317

Injury

566

Malfunction

36,831

Other

4

Total

37,718

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-1055-2016 — FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.Class I·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·20160210
• Z-1057-2016 — FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.Class I·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·20160210
• Z-1233-2015 — ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricleClass II·Terminated·Arrow International Inc·20150205
• Z-1259-2015 — Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWSClass II·Terminated·Arrow International Inc·20131108
• Z-1064-2013 — Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.Class II·Terminated·Arrow International Inc·20121127
• Z-1065-2013 — Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.Class II·Terminated·Arrow International Inc·20121127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021462.