The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System-vector Model 030606xxx-v, 030610xxx-v, 30615xxx-v, 061020xxx-v, 061030xxx-v, 101530xxx-v, 101540xx.
| Device ID | K111451 |
| 510k Number | K111451 |
| Device Name: | MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-25 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777026279 | K111451 | 000 |
| 00810170016202 | K111451 | 000 |
| 00810170016219 | K111451 | 000 |
| 00810170016226 | K111451 | 000 |
| 00810170016233 | K111451 | 000 |
| 00810170016257 | K111451 | 000 |
| 00810170016264 | K111451 | 000 |
| 00810170016271 | K111451 | 000 |
| 00811425026205 | K111451 | 000 |
| 00811425026212 | K111451 | 000 |
| 00812636026190 | K111451 | 000 |
| 00812636026220 | K111451 | 000 |
| 00812636026237 | K111451 | 000 |
| 00816777026262 | K111451 | 000 |
| 00810170016196 | K111451 | 000 |