The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil Embolic System (hes).
| Device ID | K161367 |
| 510k Number | K161367 |
| Device Name: | HydroCoil Embolic System (HES) |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Sapna Singh |
| Correspondent | Sapna Singh MICROVENTION, INC. 1311 VALENCIA AVENUE 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 | 2016-05-17 |
| Decision Date | 2016-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777026590 | K161367 | 000 |
| 00816777025449 | K161367 | 000 |
| 00816777025432 | K161367 | 000 |
| 00816777025418 | K161367 | 000 |
| 00816777025401 | K161367 | 000 |
| 00816777025395 | K161367 | 000 |
| 00816777025388 | K161367 | 000 |
| 00816777025371 | K161367 | 000 |
| 00816777025357 | K161367 | 000 |
| 00816777025340 | K161367 | 000 |
| 00816777025333 | K161367 | 000 |
| 00816777025326 | K161367 | 000 |
| 00816777025319 | K161367 | 000 |
| 00816777025234 | K161367 | 000 |
| 00811425027073 | K161367 | 000 |
| 00811425020241 | K161367 | 000 |
| 00810170016554 | K161367 | 000 |
| 00810170015861 | K161367 | 000 |
| 00816777025456 | K161367 | 000 |
| 00816777025470 | K161367 | 000 |
| 00816777025487 | K161367 | 000 |
| 00816777026583 | K161367 | 000 |
| 00816777026569 | K161367 | 000 |
| 00816777026545 | K161367 | 000 |
| 00816777026521 | K161367 | 000 |
| 00816777026514 | K161367 | 000 |
| 00816777026507 | K161367 | 000 |
| 00816777026491 | K161367 | 000 |
| 00816777026477 | K161367 | 000 |
| 00816777026453 | K161367 | 000 |
| 00816777026446 | K161367 | 000 |
| 00816777026439 | K161367 | 000 |
| 00816777026255 | K161367 | 000 |
| 00816777026248 | K161367 | 000 |
| 00816777026231 | K161367 | 000 |
| 00816777026224 | K161367 | 000 |
| 00816777026217 | K161367 | 000 |
| 00816777026200 | K161367 | 000 |
| 00810170013904 | K161367 | 000 |