510(k) K030836
K030836 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics), a Class U device. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2003
- Date Received
- March 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Wound Dressing With Thrombin Or Other Biologics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
To temporarily control bleeding and cover external wounds.