Cleared Traditional

K950179 - MEDTRONIC GC III CORONARY GUIDING CATHETER

K950179 is an FDA 510(k) clearance for MEDTRONIC GC III 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 189-day FDA review.

K950179 · Medtronics Interventional Vascular · Cardiovascular device
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Jul 1995
Decision
189d
Days
Class 2
Risk

K950179 is an FDA 510(k) clearance for the MEDTRONIC(R) GC III 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 July 25, 1995 after a review of 189 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 - K950179

510(k) Number K950179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date July 25, 1995
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
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 K950179.
MEDI-TECH PLATFORM GUIDE CATHETER
K952345 · Medi-Tech, Inc. · Aug 1995
ACS POWERBASE GUILDING CATHETER
K952205 · Advanced Cardiovascular Systems, Inc. · Aug 1995
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185 · Cordis Corp. · Aug 1995
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER
K950026 · Medtronics Interventional Vascular · Apr 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · Scimed Life Systems, Inc. · Mar 1995
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS
K944668 · Medtronics Interventional Vascular · Mar 1995