The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Pacing Lead Adaptors, Bipolar, Models Ilink-bis, Ilink-blv.
| Device ID | K031164 |
| 510k Number | K031164 |
| Device Name: | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV |
| Classification | Pacemaker Lead Adaptor |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Dockocil |
| Correspondent | Mila Dockocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00802526540608 | K031164 | 000 |
| 00802526497544 | K031164 | 000 |
| 00885672008307 | K031164 | 000 |
| 00885672008291 | K031164 | 000 |