Cleared Traditional

K912777 - CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING...

K912777 is an FDA 510(k) clearance for CORDIS 7 FRENCH 0.072 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 88-day FDA review.

K912777 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
88d
Days
Class 2
Risk

K912777 is an FDA 510(k) clearance for the CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER. 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 September 20, 1991 after a review of 88 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 - K912777

510(k) Number K912777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date September 20, 1991
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K912777.
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K913783 · Dow Corning Wright · Oct 1991
RIGHT ATRIAL CATHETERS
K911333 · Akcess Medical Products, Inc. · Sep 1991
PROFUSE INFUSION SYSTEM
K912877 · Lake Region Mfg., Inc. · Sep 1991
SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
K912191 · Mallinckrodt Medical · Jul 1991
SOFTTOUCH(R) GUIDING CATHETER
K912199 · Mallinckrodt Medical · Jul 1991
TURBO SUPPORT CATHETER
K910116 · Datascope Corp. · Jun 1991