Cleared Traditional

K942453 - GUIDE WIRE

K942453 is the FDA 510(k) clearance for GUIDE WIRE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K942453 · Boston Scientific Corp · Cardiovascular device
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Dec 1994
Decision
199d
Days
Class 2
Risk

K942453 is an FDA 510(k) clearance for the GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on December 8, 1994 after a review of 199 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K942453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1994
Decision Date December 08, 1994
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K942453.
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029 · Advanced Cardiovascular Systems, Inc. · Feb 1995
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159 · Scimed Life Systems, Inc. · Dec 1994
THE PROMPT GUIDWIRE
K943522 · Cordis Corp. · Dec 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · Advanced Cardiovascular Systems, Inc. · Jul 1994