Cleared Traditional

K022238 - MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
(FDA 510(k) Clearance)

K022238 · Medtronic Vascular · Cardiovascular

Oct 2002

Decision

90d

Days

Class 1

Risk

K022238 is an FDA 510(k) clearance for the MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626, a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 9, 2002, 90 days after receiving the submission on July 11, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number	K022238 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2002
Decision Date	October 09, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF