The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Concerto Versa, Detachable Coil.
| Device ID | K202850 |
| 510k Number | K202850 |
| Device Name: | Concerto Versa, Detachable Coil |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Rita De Rama |
| Correspondent | Rita De Rama Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000322106 | K202850 | 000 |
| 00763000321598 | K202850 | 000 |
| 00763000321567 | K202850 | 000 |
| 00763000321536 | K202850 | 000 |
| 00763000321505 | K202850 | 000 |
| 00763000321475 | K202850 | 000 |
| 00763000321444 | K202850 | 000 |
| 00763000321413 | K202850 | 000 |
| 00763000321383 | K202850 | 000 |
| 00763000321352 | K202850 | 000 |
| 00763000321321 | K202850 | 000 |
| 00763000321291 | K202850 | 000 |
| 00763000321260 | K202850 | 000 |
| 00763000321239 | K202850 | 000 |
| 00763000321208 | K202850 | 000 |
| 00763000321628 | K202850 | 000 |
| 00763000321659 | K202850 | 000 |
| 00763000322076 | K202850 | 000 |
| 00763000322045 | K202850 | 000 |
| 00763000322014 | K202850 | 000 |
| 00763000321987 | K202850 | 000 |
| 00763000321956 | K202850 | 000 |
| 00763000321925 | K202850 | 000 |
| 00763000321895 | K202850 | 000 |
| 00763000321864 | K202850 | 000 |
| 00763000321833 | K202850 | 000 |
| 00763000321802 | K202850 | 000 |
| 00763000321772 | K202850 | 000 |
| 00763000321741 | K202850 | 000 |
| 00763000321710 | K202850 | 000 |
| 00763000321680 | K202850 | 000 |
| 00763000321178 | K202850 | 000 |