Cleared Traditional

K952185 - CORDIS BRITE TIP

K952185 is an FDA 510(k) clearance for CORDIS BRITE TIP, 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 85-day FDA review.

K952185 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
85d
Days
Class 2
Risk

K952185 is an FDA 510(k) clearance for the CORDIS BRITE TIP, ENVOY 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 August 2, 1995 after a review of 85 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 - K952185

510(k) Number K952185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date August 02, 1995
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K952185.
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · Scimed Life Systems, Inc. · Sep 1995
MEDI-TECH PLATFORM GUIDE CATHETER
K952345 · Medi-Tech, Inc. · Aug 1995
ACS POWERBASE GUILDING CATHETER
K952205 · Advanced Cardiovascular Systems, Inc. · Aug 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · Scimed Life Systems, Inc. · Mar 1995
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER
K950094 · Scimed Life Systems, Inc. · Mar 1995
CANDELA SHEATH SETS
K950634 · Candela Laser Corp. · Mar 1995