AcQGuide 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 Steerable Sheath.
Pre-market Notification Details
| Device ID | K162925 |
| 510k Number | K162925 |
| Device Name: | AcQGuide Steerable Sheath |
| Classification | Catheter, Steerable |
| Applicant | ACUTUS MEDICAL, INC. 2210 FARADAY AVE SUITE 100 Carlsbad, CA 92008 |
| Contact | Brenda Clay |
| Correspondent | Brenda Clay ACUTUS MEDICAL, INC. 2210 FARADAY AVE SUITE 100 Carlsbad, CA 92008 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-19 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857042007012 | K162925 | 000 |
Trademark Results [AcQGuide Steerable Sheath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQGUIDE STEERABLE SHEATH 86757752 not registered Dead/Abandoned |
Acutus Medical Inc 2015-09-15 |
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