Cleared Traditional

K944668 - SHERPA SHERPA II AND ASCENT CORONARY GU...

K944668 is an FDA 510(k) clearance for SHERPA SHERPA II AND ASCENT CORONARY GU..., 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 171-day FDA review.

K944668 · Medtronics Interventional Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
171d
Days
Class 2
Risk

K944668 is an FDA 510(k) clearance for the SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS. 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 March 3, 1995 after a review of 171 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 - K944668

510(k) Number K944668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date March 03, 1995
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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 K944668.
MEDTRONIC(R) GC III CORONARY GUIDING CATHETER
K950179 · Medtronics Interventional Vascular · Jul 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
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER
K950094 · Scimed Life Systems, Inc. · Mar 1995
CANDELA SHEATH SETS
K950634 · Candela Laser Corp. · Mar 1995
CANDEKA DUKATIR SETS
K950635 · Candela Laser Corp. · Mar 1995