Cleared Traditional

K880722 - COATING FOR WIRE GUIDE

K880722 is an FDA 510(k) clearance for COATING FOR WIRE GUIDE, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K880722 · Cook, Inc. · Cardiovascular device
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Aug 1988
Decision
178d
Days
Class 2
Risk

K880722 is an FDA 510(k) clearance for the COATING FOR WIRE GUIDE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K880722

510(k) Number K880722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1988
Decision Date August 19, 1988
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K880722.
CORONARY GUIDE WIRE
K883579 · Datascope Corp. · Nov 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · Advanced Cardiovascular Systems, Inc. · Aug 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761 · Target Therapeutics · Aug 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · Target Therapeutics · Aug 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · Advanced Cardiovascular Systems, Inc. · Aug 1988