JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA— 510(k) K020515

Clearance details

Applicant

Jostra AG

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2002-02-15

Decision date

2002-04-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oxford, PA, US

• 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

• 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

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 →