Cleared Traditional

SHILEY FEMORAL CORONARY PERFUSION CATHETER (K881733) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881733 · Shiley, Inc. · Cardiovascular device
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Jul 1988
Decision
75d
Days
Class 2
Risk

K881733 is an FDA 510(k) clearance for the SHILEY FEMORAL CORONARY PERFUSION CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 6, 1988 after a review of 75 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 Shiley, Inc. devices

Submission Details

510(k) Number K881733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date July 06, 1988
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 122
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K881733.
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · Shiley, Inc. · Dec 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · Cook, Inc. · Sep 1988
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER
K882034 · Buckman Co., Inc. · Jul 1988
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
K881691 · Shiley, Inc. · Jul 1988
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
K881734 · Shiley, Inc. · Jul 1988
RIGHT ATRIAL CATHETER INSERTION TRAY
K881352 · Quinton, Inc. · Jun 1988