# K060016: Thromcat Thrombectomy Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Apr 25, 2006 after 112 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K901627 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021096: X-Sizer Catheter System, Ev3 Corporation (2004) Summary page 1.
- K982657: Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model AK 100, Microvena Corp. (1998) Summary page 1.

## Most influential descendants
- K072195: Thromcat Thrombectomy Catheter System (2007), 0 descendants of its own

## Recalls of this device
- May 21, 2007 · Not classified · Z-1115-2007: Defective component (power supply)
- Feb 7, 2007 · Not classified · Z-0597-2007: Face seal may wear excessively and cause particulate matter.

## Indications for use
ThromCatTM Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.

Source page: https://510kreport.com/device/K060016
Methodology: https://510kreport.com/methodology