Cleared Traditional

K925131 - CORDIS 9 F GUIDING CATHETER

K925131 is an FDA 510(k) clearance for CORDIS 9 F GUIDING CATHETER, 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 205-day FDA review.

K925131 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
205d
Days
Class 2
Risk

K925131 is an FDA 510(k) clearance for the CORDIS 9 F 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 May 6, 1993 after a review of 205 days - an extended review 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: 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 - K925131

510(k) Number K925131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date May 06, 1993
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K925131.
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · Arrow Intl., Inc. · Sep 1993
TRANSSEPTAL INTRODUCER SET
K932619 · Thomas Medical Products, Inc. · Aug 1993
ITC CATHETERS W/ HYDROMER
K922609 · Interventional Therapeutics Corp. · Apr 1993
ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
K926421 · Advanced Cardiovascular Systems, Inc. · Mar 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · Scimed Life Systems, Inc. · Feb 1993