The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Lead Terminal Pin Caps, Various Models.
| Device ID | K911142 |
| 510k Number | K911142 |
| Device Name: | LEAD TERMINAL PIN CAPS, VARIOUS MODELS |
| Classification | Pacemaker Lead Adaptor |
| Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Contact | Scott J Mindrebo |
| Correspondent | Scott J Mindrebo BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-14 |
| Decision Date | 1991-08-09 |