The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Scepter C Occlusion Balloon Catheter.
| Device ID | K121785 |
| 510k Number | K121785 |
| Device Name: | SCEPTER C OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-18 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842636020607 | K121785 | 000 |
| 00810170015816 | K121785 | 000 |
| 00810170015823 | K121785 | 000 |
| 00810170016370 | K121785 | 000 |
| 00810170018534 | K121785 | 000 |
| 00810170018541 | K121785 | 000 |
| 00810170018558 | K121785 | 000 |
| 00810170018565 | K121785 | 000 |
| 00842636020539 | K121785 | 000 |
| 00842636020546 | K121785 | 000 |
| 00842636020553 | K121785 | 000 |
| 00842636020560 | K121785 | 000 |
| 00842636020577 | K121785 | 000 |
| 00842636020584 | K121785 | 000 |
| 00842636020591 | K121785 | 000 |
| 00810170015809 | K121785 | 000 |