The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Is-1/quadripolar Terminal Cap, Part Number 6011069.
| Device ID | K950140 |
| 510k Number | K950140 |
| Device Name: | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
| Contact | Paul Mason |
| Correspondent | Paul Mason PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-13 |
| Decision Date | 1995-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734506458 | K950140 | 000 |