SENTRA

Pacemaker Lead Adaptor

CARDIAC PACEMAKERS, INC.

The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Sentra.

Pre-market Notification Details

• Device ID: K843060
• 510k Number: K843060
• Device Name: SENTRA
• Classification: Pacemaker Lead Adaptor
• Applicant: CARDIAC PACEMAKERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DTD
• CFR Regulation Number: 870.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-08-03
• Decision Date: 1984-09-20