Cleared Traditional

K943896 - GUIDE WIRE FOR THE USE WITH DATASCOPE P...

K943896 is the FDA 510(k) clearance for GUIDE WIRE FOR THE USE WITH DATASCOPE P... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 499-day FDA review.

K943896 · Datascope Corp. · Cardiovascular device
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Dec 1995
Decision
499d
Days
Class 2
Risk

K943896 is an FDA 510(k) clearance for the GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 499 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Datascope Corp. devices

Submission Details

510(k) Number K943896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1994
Decision Date December 22, 1995
Days to Decision 499 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
374d slower than avg
Panel avg: 125d · This submission: 499d
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 454
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K943896.
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · Scimed Life Systems, Inc. · Apr 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · Advanced Cardiovascular Systems, Inc. · Apr 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · Terumo Medical Corp. · Feb 1996
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · Cordis Corp. · Nov 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · Terumo Medical Corp. · Oct 1995
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995