# K210012: Tamarin Blue PTCA RX Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Natec Medical, Ltd.
- Decided: Jul 9, 2021 after 186 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P790017 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112735: Tamarin Blue Ptca RX Dilatation Catheter, Natec Medical, Ltd. (2012) Summary page 5.

## Indications for use
The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

Source page: https://510kreport.com/device/K210012
Methodology: https://510kreport.com/methodology