AcQGuide MAX Steerable Sheath— 510(k) K211100
Substantially EquivalentAcutus Medical, Inc.
FDA 510(k) clearance K211100 for AcQGuide MAX Steerable Sheath, Substantially Equivalent on 2021-05-14. Applicant: Acutus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Acutus Medical, Inc.
- Product code
- Code DRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1280
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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More clearances from Acutus Medical, Inc.
view allAdverse events under product code DRA
product code DRA- Death
- 156
- Injury
- 3,133
- Malfunction
- 6,266
- Total
- 9,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.