D-Stat Radial Topical Hemostat
FDA 510(k) clearance K200720 · decided 2020-06-26
Clearance details
- K-number
- K200720
- Device name
- D-Stat Radial Topical Hemostat
- Applicant
- Vascular Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-03-19
- Decision date
- 2020-06-26
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- QSX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.