The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Mindframe Capture Lp Revascularization Device.
| Device ID | K141516 |
| 510k Number | K141516 |
| Device Name: | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE |
| Classification | Catheter, Thrombus Retriever |
| Applicant | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-09 |
| Decision Date | 2015-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536020191 | K141516 | 000 |
| 00847536020184 | K141516 | 000 |
| 00847536020177 | K141516 | 000 |
| 00847536020160 | K141516 | 000 |
| 00847536020153 | K141516 | 000 |
| 00847536020146 | K141516 | 000 |
| 00847536020139 | K141516 | 000 |
| 00847536020122 | K141516 | 000 |