Cleared Traditional

K001245 - 3T L. V. CONTROL VALVE
(FDA 510(k) Clearance)

K001245 · 3t Medical Systems, LLC · Cardiovascular

Aug 2001

Decision

484d

Days

Class 2

Risk

K001245 is an FDA 510(k) clearance for the 3T L. V. CONTROL VALVE. This device is classified as a Cpb Check Valve, Retrograde Flow, In-line (Class II — Special Controls, product code MJJ).

Submitted by 3t Medical Systems, LLC (Troy, US). The FDA issued a Cleared decision on August 15, 2001, 484 days after receiving the submission on April 18, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number	K001245 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2000
Decision Date	August 15, 2001
Days to Decision	484 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement