The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Turbohawk Plus Directional Atherectomy System.
| Device ID | K212027 |
| 510k Number | K212027 |
| Device Name: | TurboHawk Plus Directional Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Medtronic, Inc 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Jenny Andersen |
| Correspondent | Jenny Andersen Medtronic, Inc 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-29 |
| Decision Date | 2021-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000402433 | K212027 | 000 |
| 00763000402419 | K212027 | 000 |
| 00763000402396 | K212027 | 000 |
| 00763000402372 | K212027 | 000 |
| 00763000402358 | K212027 | 000 |