# K090101: Equistream Long-Term Hemodialysis Catheters

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 10, 2009 after 26 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981994 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.

## Recalls of this device
- May 31, 2019 · Class II · Z-2373-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2380-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2372-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2378-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2375-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2370-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2382-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2369-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2376-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2377-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2379-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2381-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2371-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2374-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2368-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

## Indications for use
The EQUISTREAM TM long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion, and apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters greater than 40cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K090101
Methodology: https://510kreport.com/methodology