The following data is part of a premarket notification filed by Front Line Medical Technologies, Inc. with the FDA for Cobra-os Kit.
| Device ID | K201652 |
| 510k Number | K201652 |
| Device Name: | COBRA-OS Kit |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Front Line Medical Technologies, Inc. 184 Paul Street, Unit 1 London, CA N6hil2 |
| Contact | Asha Parekh |
| Correspondent | Sharon Iverson Covance 5353 Wayzata Blvd. Suite 505 Minneapolis, MN 55416 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-18 |
| Decision Date | 2021-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16286780610009 | K201652 | 000 |
| 16286780610023 | K201652 | 000 |
| 16286780610016 | K201652 | 000 |
| 10628678061023 | K201652 | 000 |
| 10628678061016 | K201652 | 000 |
| 10628678061009 | K201652 | 000 |
| 10628678061061 | K201652 | 000 |
| 10628678061054 | K201652 | 000 |