Cleared Traditional

K962362 - CORDIS ENVOY & VISTA BRITE TIP GUIDING ...

K962362 is an FDA 510(k) clearance for CORDIS ENVOY & VISTA BRITE TIP 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 50-day FDA review.

K962362 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
50d
Days
Class 2
Risk

K962362 is an FDA 510(k) clearance for the CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS. 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 8, 1996 after a review of 50 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 - K962362

510(k) Number K962362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date August 08, 1996
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 K962362.
VISTA BRITE TIP CATHETERS
K963962 · Cordis Corp. · May 1997
VISTA BRITE TIP CATHETERS
K965211 · Cordis Corp. · Mar 1997
VISTA BRITE TIP CATHETERS
K962830 · Cordis Corp. · Oct 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · Scimed Life Systems, Inc. · May 1996
SCIMED ANGIOGRAPHIC KITS
K953265 · Scimed Life Systems, Inc. · Jan 1996
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995