The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Hawkone Directional Atherectomy System.
| Device ID | K161361 |
| 510k Number | K161361 |
| Device Name: | HawkOne Directional Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Medtronic Vascular, Inc. (formerly D.b.a Ev3 Inc., Covidien Llc) 3033 Campus Drive Plymouth, MN 55441 |
| Contact | Rupali Gupta |
| Correspondent | Rupali Gupta Medtronic Vascular, Inc. (formerly D.b.a Ev3 Inc., Covidien Llc) 3033 Campus Drive Plymouth, MN 55441 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169968356 | K161361 | 000 |
| 00643169968332 | K161361 | 000 |
| 00643169792319 | K161361 | 000 |
| 00643169792302 | K161361 | 000 |
| 00643169777644 | K161361 | 000 |
| 00643169728783 | K161361 | 000 |
| 00643169728769 | K161361 | 000 |