The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil Embolic System (hes).
| Device ID | K112226 |
| 510k Number | K112226 |
| Device Name: | HYDROCOIL EMBOLIC SYSTEM (HES) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-03 |
| Decision Date | 2011-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777027214 | K112226 | 000 |
| 00811425026755 | K112226 | 000 |
| 00811425026748 | K112226 | 000 |
| 00811425026731 | K112226 | 000 |
| 00811425020333 | K112226 | 000 |
| 00811425020326 | K112226 | 000 |
| 00811425020319 | K112226 | 000 |
| 00811425020302 | K112226 | 000 |
| 00811425020289 | K112226 | 000 |
| 00811425020272 | K112226 | 000 |
| 00810170017193 | K112226 | 000 |
| 00810170017186 | K112226 | 000 |
| 00810170017179 | K112226 | 000 |
| 00810170017162 | K112226 | 000 |
| 00810170017155 | K112226 | 000 |
| 00810170017148 | K112226 | 000 |
| 00810170017131 | K112226 | 000 |
| 00810170017124 | K112226 | 000 |
| 00811425026762 | K112226 | 000 |
| 00811425026779 | K112226 | 000 |
| 00811425026786 | K112226 | 000 |
| 00816777023292 | K112226 | 000 |
| 00816777023285 | K112226 | 000 |
| 00816777023278 | K112226 | 000 |
| 00816777023261 | K112226 | 000 |
| 00816777023254 | K112226 | 000 |
| 00812636029542 | K112226 | 000 |
| 00812636029528 | K112226 | 000 |
| 00812636029511 | K112226 | 000 |
| 00812636029504 | K112226 | 000 |
| 00812636029498 | K112226 | 000 |
| 00812636029481 | K112226 | 000 |
| 00812636029474 | K112226 | 000 |
| 00812636029467 | K112226 | 000 |
| 00812636029450 | K112226 | 000 |
| 00811425026823 | K112226 | 000 |
| 00811425026809 | K112226 | 000 |
| 00811425026793 | K112226 | 000 |
| 00810170010293 | K112226 | 000 |