Cleared Traditional

K950156 - ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE

K950156 is the FDA 510(k) clearance for ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K950156 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
78d
Days
Class 2
Risk

K950156 is an FDA 510(k) clearance for the ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K950156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date April 05, 1995
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K950156.
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
K950266 · Scimed Life Systems, Inc. · Apr 1995
CORDIS STEERABLE GUIDEWIRES
K950316 · Cordis Corp. · Apr 1995
DASHER-14
K950069 · Target Therapeutics · Apr 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240 · Scimed Life Systems, Inc. · Mar 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113 · Scimed Life Systems, Inc. · Mar 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141 · Scimed Life Systems, Inc. · Mar 1995