# K152497: PW Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Tatara Vascular, LLC
- Decided: Jan 22, 2016 after 143 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890505 (1989). 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)
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 4.
- K052339: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2005) Summary page 4.

## Indications for use
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.

Source page: https://510kreport.com/device/K152497
Methodology: https://510kreport.com/methodology