# K002902: Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company
- Decided: Apr 9, 2001 after 203 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) (2002), 9 descendants of its own
- K043292: Hemocath (2005), 3 descendants of its own
- K062901: Hemocath II (2007), 2 descendants of its own
- K071202: Dermaport Percutaneous Vascular Access System (Pvas) (2007), 1 descendant of its own
- K041559: 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (2004), 1 descendant of its own

## Recalls of this device
- Mar 20, 2003 · Not classified · Z-0744-03: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Mar 20, 2003 · Not classified · Z-0742-03: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Mar 20, 2003 · Not classified · Z-0743-03: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Mar 20, 2003 · Not classified · Z-0746-03: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Mar 20, 2003 · Not classified · Z-0747-03: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter

Source page: https://510kreport.com/device/K002902
Methodology: https://510kreport.com/methodology