The following data is part of a premarket notification filed by Capture Vascular, Inc. with the FDA for Megavac Mechanical Thrombectomy System.
| Device ID | K171493 |
| 510k Number | K171493 |
| Device Name: | MegaVac Mechanical Thrombectomy System |
| Classification | Catheter, Embolectomy |
| Applicant | Capture Vascular, Inc. 620 Mountain Village Blvd. Suite 2c Mountain Village, CO 81435 |
| Contact | Aaron Call |
| Correspondent | Aaron Call Capture Vascular, Inc. 620 Mountain Village Blvd. Suite 2c Mountain Village, CO 81435 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-22 |
| Decision Date | 2017-08-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEGAVAC MECHANICAL THROMBECTOMY SYSTEM 87685679 not registered Dead/Abandoned |
Capture Vascular Inc. 2017-11-15 |