The following data is part of a premarket notification filed by Truvic Medical Inc. with the FDA for Prodigy Thrombectomy System.
| Device ID | K214114 |
| 510k Number | K214114 |
| Device Name: | Prodigy Thrombectomy System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Truvic Medical Inc. 1359 Dell Ave Campbell, CA 95008 |
| Contact | Micheal Buck |
| Correspondent | Semih Oktay CardioMed Device Consultants 1783 Forest Drive, Suite 254 Annapolis, MD 21401 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-30 |
| Decision Date | 2022-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08500320790084 | K214114 | 000 |
| 00850032079013 | K214114 | 000 |
| 00850032079006 | K214114 | 000 |
| 00850032079082 | K214114 | 000 |
| 00850032079075 | K214114 | 000 |
| 00850032079068 | K214114 | 000 |
| 00850032079051 | K214114 | 000 |
| 00850032079044 | K214114 | 000 |
| 00850032079150 | K214114 | 000 |
| 00850032079020 | K214114 | 000 |
| 00850032079037 | K214114 | 000 |
| 08500320790077 | K214114 | 000 |
| 08500320790060 | K214114 | 000 |
| 08500320790053 | K214114 | 000 |
| 08500320790046 | K214114 | 000 |
| 08500320790039 | K214114 | 000 |
| 08500320790022 | K214114 | 000 |
| 08500320790015 | K214114 | 000 |
| 08500320790008 | K214114 | 000 |
| 00850032079143 | K214114 | 000 |