Cleared Traditional

K882796 - SLIP-COAT(TM) CATHETERS

K882796 is an FDA 510(k) clearance for SLIP-COAT(TM) CATHETERS, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K882796 · Cook, Inc. · Cardiovascular device
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Jul 1988
Decision
22d
Days
Class 2
Risk

K882796 is an FDA 510(k) clearance for the SLIP-COAT(TM) CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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.

FDA 510(k) Submission Details - K882796

510(k) Number K882796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1988
Decision Date July 28, 1988
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 499
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K882796.
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
K882655 · Procedure Packs, Inc. · Sep 1988
NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS
K875127 · Novoste Corp. · Aug 1988
HEPARIN COATED LUMINAL PACING CATHETER
K875337 · Spectramed, Inc. · May 1988
FIBEROPTIC CATHETER
K880661 · Optimed Technologies, Inc. · May 1988
MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
K875325 · Schneider-Shilley (Usa) · Feb 1988
K882796 · SLIP-COAT(TM) CATHETERS
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