510(k) K243553
K243553 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "QuikClot Control+ Hemostatic Device". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code POD (Temporary, Internal Use Hemostatic), a Class II device regulated under 21 CFR 878.4454. Teleflex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2025
- Date Received
- November 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary, Internal Use Hemostatic
- Device Class
- Class II
- Regulation Number
- 878.4454
- Review Panel
- SU
- Submission Type
Intended to control severely bleeding wounds