Cleared Traditional

K973708 - TOMCAT GUIDE WIRE

K973708 is the FDA 510(k) clearance for TOMCAT GUIDE WIRE by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K973708 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
81d
Days
Class 2
Risk

K973708 is an FDA 510(k) clearance for the TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 81 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K973708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1997
Decision Date December 19, 1997
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 K973708.
LUGE GUIDE WIRE
K973945 · Scimed Life Systems, Inc. · Jan 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · Cordis Corp. · Jan 1998
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · B.Braun Medical, Inc. · Dec 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
K973494 · Guidant Corp. · Dec 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
K971281 · Medcomp · Oct 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · Guidant Corp. · Sep 1997