Cleared Special

ENVOY AND VISTA BRITE TIP (K982632) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K982632 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
26d
Days
Class 2
Risk

K982632 is an FDA 510(k) clearance for the ENVOY AND VISTA BRITE TIP. 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 18, 1998 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corp. devices

Submission Details

510(k) Number K982632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1998
Decision Date August 18, 1998
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 344
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K982632.
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
GT LEGGIERO
K981359 · Terumo Medical Corp. · Jan 1999
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · Scimed Life Systems, Inc. · Feb 1998
CERTODYN RAECG UNIVERSAL ADAPTER
K973371 · B.Braun Medical, Inc. · Nov 1997