Cleared Traditional

K911703 - CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING...

K911703 is an FDA 510(k) clearance for CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K911703 · Cordis Corp. · Cardiovascular device
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Jun 1991
Decision
73d
Days
Class 2
Risk

K911703 is an FDA 510(k) clearance for the CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 73 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.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K911703

510(k) Number K911703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1991
Decision Date June 28, 1991
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K911703.
SCIMED 7 FR. & 8 FR.
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K911367 · Baxter Healthcare Corp · Jun 1991
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K910204 · Baxter Healthcare Corp · Apr 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991