Cleared Traditional

K925283 - VALVULOTOME (FDA 510(k) Clearance)

K925283 · Intramed Laboratories, Inc. · Cardiovascular device

Feb 1994

Decision

478d

Days

Class 2

Risk

K925283 is an FDA 510(k) clearance for the VALVULOTOME. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 10, 1994, 478 days after receiving the submission on October 20, 1992.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number	K925283 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 1992
Decision Date	February 10, 1994
Days to Decision	478 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF