JOSTRA ARTERIAL PERFUSION CANNULAE— 510(k) K012774

Name: FDA 510(k) clearance K012774
Creator: U.S. Food and Drug Administration
Published: 2001-11-16

Substantially Equivalent

Jostra AG

FDA 510(k) clearance K012774 for JOSTRA ARTERIAL PERFUSION CANNULAE, Substantially Equivalent on 2001-11-16. Applicant: Jostra AG. Device class: 2.

Clearance details

Applicant: Jostra AG
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2001-08-20
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWF

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K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
K250937 — Venous Return Cannulae2026-03-11
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
K253671 — Dual Stage Venous Cannulae2026-01-30

More clearances from Jostra AG

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K020983 — JOSTRA SUCKERS, MODEL JS2004-01-30
K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 20302003-02-26
K020784 — JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS2003-01-09
K023132 — JOSTRA MECC SYSTEM2002-12-17
K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV2002-09-11

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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 →

Recalls naming K012774

K-number listed on FDA's recall record

Z-2159-2018 — Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypassClass II·Terminated·Maquet Cardiopulmonary Ag·20180514
Z-2160-2018 — Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypassClass II·Terminated·Maquet Cardiopulmonary Ag·20180514
Z-2161-2018 — Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypassClass II·Terminated·Maquet Cardiopulmonary Ag·20180514

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012774.

Data sourced from openFDA. This site is unofficial and independent of the FDA.