CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET— 510(k) K121403
Substantially EquivalentTeleflex, Inc.
FDA 510(k) clearance K121403 for CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET, Substantially Equivalent on 2012-06-20. Applicant: Teleflex, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflex, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reading, PA, US
Recent devices under product code CAZ
view allMore clearances from Teleflex, Inc.
view all- K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
- K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
- K141940 — CONCHASMART COLUMN
- K140556 — CONCHASMART BREATHING CIRCUIT
- K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121403
K-number listed on FDA's recall record- Z-2364-2026 — Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K
- Z-1239-2020 — Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
- Z-1241-2020 — Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
- Z-1253-2020 — (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
- Z-1958-2018 — Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
- Z-0573-2015 — Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
- Z-0546-2014 — Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.