# K053589: Long-Term Hemodialysis Catheters with Biobloc Coating

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Apr 13, 2006 after 111 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- 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: 6 generations back to K981994 (1998). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030020: Hemosplit Long-Term Hemodialysis Catheter, C.R. Bard, Inc. (2003) Summary page 1.
- K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters, C.R. Bard, Inc. (2005) Summary page 1.
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro, Arrow Intl., Inc. (2000) Summary page 2.

## Most influential descendants
- K063245: Elutia  Coated Closed Surgical Wound Drain (2007), 0 descendants of its own

## Indications for use
HemoSplit® and HemoStarTM long-term hemodialysis catheters with BioBlocTM coating are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion. The performance of the BioBloCTM coating on the HemoSplit® and HemoStarTM catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing.

Source page: https://510kreport.com/device/K053589
Methodology: https://510kreport.com/methodology