The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil Embolic Systems (hes).
| Device ID | K071939 |
| 510k Number | K071939 |
| Device Name: | HYDROCOIL EMBOLIC SYSTEMS (HES) |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2008-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810170012577 | K071939 | 000 |
| 10810170012256 | K071939 | 000 |
| 10810170012249 | K071939 | 000 |
| 10810170012232 | K071939 | 000 |
| 10810170012225 | K071939 | 000 |
| 10810170012218 | K071939 | 000 |
| 10810170012201 | K071939 | 000 |
| 10810170012195 | K071939 | 000 |
| 10810170012188 | K071939 | 000 |
| 10810170012171 | K071939 | 000 |
| 10810170012164 | K071939 | 000 |
| 10810170012157 | K071939 | 000 |
| 10810170012140 | K071939 | 000 |
| 10810170012263 | K071939 | 000 |
| 10810170012270 | K071939 | 000 |
| 10810170012447 | K071939 | 000 |
| 10810170012560 | K071939 | 000 |
| 10810170012553 | K071939 | 000 |
| 10810170012546 | K071939 | 000 |
| 10810170012539 | K071939 | 000 |
| 10810170012522 | K071939 | 000 |
| 10810170012515 | K071939 | 000 |
| 10810170012508 | K071939 | 000 |
| 10810170012492 | K071939 | 000 |
| 10810170012485 | K071939 | 000 |
| 10810170012478 | K071939 | 000 |
| 10810170012461 | K071939 | 000 |
| 10810170012454 | K071939 | 000 |
| 10810170012133 | K071939 | 000 |