The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Model P In-line Bipolar Endocardial Tined Lead.
| Device ID | K915188 |
| 510k Number | K915188 |
| Device Name: | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Contact | Richard E Shirey |
| Correspondent | Richard E Shirey COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-09-11 |