Cleared Traditional

K882771 - EXTRACORPOREAL MEMBRANE OXYGENATION CAT...

K882771 is the FDA 510(k) clearance for EXTRACORPOREAL MEMBRANE OXYGENATION CAT... by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K882771 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
83d
Days
Class 2
Risk

K882771 is an FDA 510(k) clearance for the EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 27, 1988 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook, Inc. devices

Submission Details

510(k) Number K882771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1988
Decision Date September 27, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K882771.
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · Quinton, Inc. · Feb 1989
ANGIOPUMP TUBING SET
K884310 · Olympus Corp. · Jan 1989
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · Shiley, Inc. · Dec 1988
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER
K882034 · Buckman Co., Inc. · Jul 1988
SHILEY FEMORAL CORONARY PERFUSION CATHETER
K881733 · Shiley, Inc. · Jul 1988
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
K881691 · Shiley, Inc. · Jul 1988