AcQGuide® VUE Steerable Sheath
Catheter, Steerable
Acutus Medical, Inc.
The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqguide® Vue Steerable Sheath.
Pre-market Notification Details
| Device ID | K221044 |
| 510k Number | K221044 |
| Device Name: | AcQGuide® VUE Steerable Sheath |
| Classification | Catheter, Steerable |
| Applicant | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 |
| Contact | Sarah Clay |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-04-08 |
| Decision Date | 2022-05-05 |
Trademark Results [AcQGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQGUIDE 87246283 5308281 Live/Registered |
Acutus Medical, Inc. 2016-11-23 |
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