WOLF Thrombectomy Device
Catheter, Embolectomy
880 Medical, LLC
The following data is part of a premarket notification filed by 880 Medical, Llc with the FDA for Wolf Thrombectomy Device.
Pre-market Notification Details
| Device ID | K182835 |
| 510k Number | K182835 |
| Device Name: | WOLF Thrombectomy Device |
| Classification | Catheter, Embolectomy |
| Applicant | 880 Medical, LLC 46714 Fremont Blvd. Fremont, CA 94538 |
| Contact | Micheal P. Wallace |
| Correspondent | Roberta Hines Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98077 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-03-27 |
Trademark Results [WOLF Thrombectomy Device]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WOLF THROMBECTOMY DEVICE 88517929 not registered Live/Pending |
Devoro Medical Inc. 2019-07-16 |
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