# K931009: Tyshak Peripheral Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Dec 21, 1993 after 305 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013601: Numed Mullins Pta Catheter (2002), 2 descendants of its own
- K991977: Tyshak, Model 102 and Z-Med, Model 302 (2000), 2 descendants of its own
- K050857: Bib Pta Balloon Catheter (2005), 1 descendant of its own
- K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (2004), 1 descendant of its own
- K160889: BIB Stent Placement Catheter (2016), 0 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0509-2010: The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The produc

Source page: https://510kreport.com/device/K931009
Methodology: https://510kreport.com/methodology