Cleared Traditional

K960657 - SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT...

K960657 is the FDA 510(k) clearance for SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K960657 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
73d
Days
Class 2
Risk

K960657 is an FDA 510(k) clearance for the SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 29, 1996 after a review of 73 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K960657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1996
Decision Date April 29, 1996
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K960657.
LRM
K960718 · Lake Region Mfg., Inc. · May 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015 · Scimed Life Systems, Inc. · May 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · Scimed Life Systems, Inc. · Apr 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · Advanced Cardiovascular Systems, Inc. · Apr 1996
ESSENCE GUIDEWIRE
K955637 · Cordis Neurovascular, Inc. · Mar 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · Terumo Medical Corp. · Feb 1996