Cleared Traditional

K921310 - CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CA...

K921310 is an FDA 510(k) clearance for CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CA..., 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 182-day FDA review.

K921310 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
182d
Days
Class 2
Risk

K921310 is an FDA 510(k) clearance for the CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 182 days - an extended review 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K921310

510(k) Number K921310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date September 17, 1992
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 K921310.
INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
K921845 · Becton Dickinson Vascular Access, Inc. · Nov 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480 · Scimed Life Systems, Inc. · Oct 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726 · Baxter Healthcare Corp · Sep 1992
LUKENS 2-0 BRAIDED SILK SUTURES
K922254 · Quinton, Inc. · Sep 1992
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980 · C.R. Bard, Inc. · Aug 1992
CARDIAC CATHERIZATION KIT
K914299 · Abbott Laboratories · Jun 1992