The following data is part of a premarket notification filed by Microvention Inc. with the FDA for Scepter Mini Occlusion Balloon Catheter.
| Device ID | K182829 |
| 510k Number | K182829 |
| Device Name: | Scepter Mini Occlusion Balloon Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Marina Emond |
| Correspondent | Marina Emond MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-05 |
| Decision Date | 2019-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842429106563 | K182829 | 000 |