VASOBand Vascular Compression Device
FDA 510(k) clearance K203803 · decided 2021-01-26
Clearance details
- K-number
- K203803
- Device name
- VASOBand Vascular Compression Device
- Applicant
- Vasoinnovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-28
- Decision date
- 2021-01-26
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South Pasadena, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.