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 |