The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Permanent Lead Introducer, Various Mdls.
| Device ID | K911236 |
| 510k Number | K911236 |
| Device Name: | MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS |
| Classification | Introducer, Catheter |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Tracy A Malm |
| Correspondent | Tracy A Malm MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-20 |
| Decision Date | 1991-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10613994397826 | K911236 | 000 |
| 00681490143127 | K911236 | 000 |
| 00681490143011 | K911236 | 000 |
| 00681490142977 | K911236 | 000 |
| 10721902577663 | K911236 | 000 |
| 10721902577656 | K911236 | 000 |
| 10721902577649 | K911236 | 000 |
| 10721902577632 | K911236 | 000 |
| 10721902577625 | K911236 | 000 |
| 00721902577536 | K911236 | 000 |
| 00721902577482 | K911236 | 000 |
| 00681490143172 | K911236 | 000 |
| 00681490143295 | K911236 | 000 |
| 10613994391589 | K911236 | 000 |
| 10613994391572 | K911236 | 000 |
| 10613994391565 | K911236 | 000 |
| 10613994391558 | K911236 | 000 |
| 10681490143858 | K911236 | 000 |
| 00681490143844 | K911236 | 000 |
| 00681490143653 | K911236 | 000 |
| 00681490143509 | K911236 | 000 |
| 00681490143455 | K911236 | 000 |
| 00681490143349 | K911236 | 000 |
| 00721902577468 | K911236 | 000 |