The following data is part of a premarket notification filed by Contego Medical Inc. with the FDA for Excipio Sv Thrombectomy Device.
| Device ID | K221204 |
| 510k Number | K221204 |
| Device Name: | Excipio SV Thrombectomy Device |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 |
| Contact | Jim Clossick |
| Correspondent | Jim Clossick Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851616007491 | K221204 | 000 |