Cleared Traditional

K915374 - CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING...

K915374 is an FDA 510(k) clearance for CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K915374 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
77d
Days
Class 2
Risk

K915374 is an FDA 510(k) clearance for the CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K915374

510(k) Number K915374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date February 14, 1992
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K915374.
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992
RIGHT ATRIAL CATHETER KITS
K920331 · Akcess Medical Products, Inc. · Apr 1992
TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
K915521 · Target Therapeutics · Mar 1992
CORDIS SHUTTLE CATHETER
K915777 · Cordis Corp. · Feb 1992
ITC GUIDING CATHETER
K913052 · Interventional Therapeutics Corp. · Nov 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · Scimed Life Systems, Inc. · Nov 1991