Cleared Traditional

K953417 - MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
(FDA 510(k) Clearance)

K953417 · Cook Pacemaker Corp. · Cardiovascular

Sep 1995

Decision

113d

Days

Class 3

Risk

K953417 is an FDA 510(k) clearance for the MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS. This device is classified as a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY).

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on September 29, 1995, 113 days after receiving the submission on June 8, 1995.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number	K953417 FDA.gov
FDA Decision	Cleared ST
Date Received	June 08, 1995
Decision Date	September 29, 1995
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—