Cleared Traditional

CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (K952562) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952562 · Cardio Metrics, Inc. · Cardiovascular device
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Aug 1995
Decision
88d
Days
Class 2
Risk

K952562 is an FDA 510(k) clearance for the CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardio Metrics, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 29, 1995 after a review of 88 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 Cardio Metrics, Inc. devices

Submission Details

510(k) Number K952562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date August 29, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 228
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K952562.
USCI COMMANDER SERIES GUIDE WIRES
K961271 · C.R. Bard, Inc. · Jun 1996
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · Cordis Corp. · Nov 1995
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · Cordis Corp. · Jul 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · Baxter Healthcare Corp · Jun 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · Boston Scientific Corp · Jun 1995