The following data is part of a premarket notification filed by Silk Road Medical, Inc. with the FDA for Enroute Enflate Transcarotid Rx Balloon Dilatation Catheter.
| Device ID | K221414 |
| 510k Number | K221414 |
| Device Name: | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Silk Road Medical, Inc. 1213 Innsbruck Drive Sunnyvale, CA 94089 |
| Contact | Denise Aycox |
| Correspondent | Denise Aycox Silk Road Medical, Inc. 1213 Innsbruck Drive Sunnyvale, CA 94089 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811311020928 | K221414 | 000 |
| 00811311021031 | K221414 | 000 |
| 00811311021024 | K221414 | 000 |
| 00811311020966 | K221414 | 000 |
| 00811311020959 | K221414 | 000 |