Cleared Traditional

K950490 - MEDTRONIC GC IV CORONARY GUIDING CATHETER

K950490 is an FDA 510(k) clearance for MEDTRONIC GC IV CORONARY GUIDING CATHETER, manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K950490 · Medtronics Interventional Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
288d
Days
Class 2
Risk

K950490 is an FDA 510(k) clearance for the MEDTRONIC GC IV CORONARY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 288 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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K950490

510(k) Number K950490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date November 21, 1995
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
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 648
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K950490.
MEDTRONIC SHERPA GUIDING CATHETER
K955651 · Medtronics Interventional Vascular · Jan 1996
SCIMED ANGIOGRAPHIC KITS
K953265 · Scimed Life Systems, Inc. · Jan 1996
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · Cordis Neurovascular, Inc. · Oct 1995
FASGUIDE
K951159 · Target Therapeutics · Sep 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · Scimed Life Systems, Inc. · Sep 1995