Cleared Traditional

K973708 - TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL (FDA 510(k) Clearance)

K973708 · Merit Medical Systems, Inc. · Cardiovascular device

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. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 19, 1997, 81 days after receiving the submission on September 29, 1997.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.

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