# K191275: All’InCath 035M PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nexstep Medical
- Decided: Jan 15, 2020 after 247 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 8 generations back to K001134 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140351: Arrow Gpscath Balloon Dilatation Catheter, Hotspur Technologies,Inc Subsidiary of Teleflex ME (2014) Summary page 5.

## Indications for use
The All’InCath 035M PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The All’InCath 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K191275
Methodology: https://510kreport.com/methodology