510(k) K131060
K131060 is an FDA 510(k) premarket notification submitted by Pursuit Vascular, Inc. for the device "CLEARGUARD HD END CAP". The FDA issued a decision of Substantially Equivalent on December 16, 2013. The device falls under product code PEH (Hemodialysis Catheter Luer End Cap), a Class II device regulated under 21 CFR 876.5540. Pursuit Vascular, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2013
- Date Received
- April 16, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemodialysis Catheter Luer End Cap
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
For use in hemodialysis catheters to reduce hub infection.