# K011576: Medcomp Ash Split

- Pathway: 510(k) (Special)
- Applicant: Medical Components, Inc.
- Decided: Jun 21, 2001 after 30 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- 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
Longest line of descent: 1 generation back to K972207 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM, Medcomp (1998) Summary page 1.

## Indications for use
The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medcomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

Source page: https://510kreport.com/device/K011576
Methodology: https://510kreport.com/methodology