Cleared Traditional

K942453 - GUIDE WIRE

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

K942453 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K942453

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.

DQX Device Classification - Class 2, Special Controls

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 681
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
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022 · Cardio Metrics, Inc. · Sep 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994