# K981994: Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 3, 1998 after 87 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
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K8714: Vas-Cath Soft-Cell Catheter. Number could not be read Summary page 2.

## Most influential descendants
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter (2002), 38 descendants of its own
- K020465: Medcomp Ash Split-Cath II (2002), 29 descendants of its own
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 (2003), 13 descendants of its own
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), 12 descendants of its own
- K022678: Medcomp SC4 (2003), 11 descendants of its own

## Indications for use
The Opti-Flow Dual Lumen Catheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.

Source page: https://510kreport.com/device/K981994
Methodology: https://510kreport.com/methodology