# K131060: Clearguard HD End Cap

- Pathway: 510(k) (Traditional)
- Applicant: Pursuit Vascular, Inc.
- Decided: Dec 16, 2013 after 244 days
- Product code: PEH (Hemodialysis Catheter Luer End Cap)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Corporation Vaxcel™ Plus Chronic Dialysis Catheter: named in the summary without a submission number

## Most influential descendants
- K180111: ClearGuard HD Antimicrobial Barrier Cap (2018), 0 descendants of its own

## Indications for use
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcusfaecium (I/RE), Enterococcusfoecalis (I/RE), Acinetobacter baumannit, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE%, Pseudomonos aeruginoso, Candida olbi cans and Candida parapsilosis and has not been shown to be effective against Condida paratropica/is and Kiebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.

Source page: https://510kreport.com/device/K131060
Methodology: https://510kreport.com/methodology