TRANSLUMINAL BIPOLAR PACING PROBE

Electrode, Pacemaker, Temporary

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Transluminal Bipolar Pacing Probe.

Pre-market Notification Details

• Device ID: K813521
• 510k Number: K813521
• Device Name: TRANSLUMINAL BIPOLAR PACING PROBE
• Classification: Electrode, Pacemaker, Temporary
• Applicant: AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: LDF
• CFR Regulation Number: 870.3680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-12-16
• Decision Date: 1982-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690103194579	K813521	000