The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Hawkone Directional Atherectomy System.
| Device ID | K141801 |
| 510k Number | K141801 |
| Device Name: | HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | COVIDIEN, LLC 3033 CAMPUS DRIVE Plymouth, MN 55442 |
| Contact | Julie Underdahl |
| Correspondent | Julie Underdahl COVIDIEN, LLC 3033 CAMPUS DRIVE 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 | 2014-07-03 |
| Decision Date | 2014-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169968554 | K141801 | 000 |
| 00643169968509 | K141801 | 000 |
| 00643169968486 | K141801 | 000 |
| 00821684073551 | K141801 | 000 |
| 00821684057964 | K141801 | 000 |
| 00821684057933 | K141801 | 000 |
| 00821684057926 | K141801 | 000 |
| 00763000202699 | K141801 | 000 |