# K013601: Numed Mullins Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Jan 3, 2002 after 64 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931009 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931009: Tyshak Peripheral Balloon Dilation Catheter, NuMED, Inc. (1993). Our OCR of the scanned summary read “K931009” beside “510(k)”; FDA’s K931009 is the only number that fits it and carries the summary’s name for the device. Summary page 1.

## Most influential descendants
- K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters (2004), 1 descendant of its own
- K153069: Edwards Balloon Catheter (2016), 0 descendants of its own

## Indications for use
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K013601
Methodology: https://510kreport.com/methodology