# K112735: Tamarin Blue Ptca RX Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Nov 2, 2012 after 409 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: 2 generations back to P790017 (1980). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 1.
- K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2011) Summary page 1.
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon, Medtronic, Ireland (2010) Summary page 2.

## Most influential descendants
- K131169: Mozec - RX Ptca Balloon Dilatation Catheter (2013), 2 descendants of its own
- K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter (2016), 1 descendant of its own
- K210012: Tamarin Blue PTCA RX Dilatation Catheter (2021), 0 descendants of its own
- K181023: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own
- K141933: Filao NC RX Ptca Dilatation Catheter (2015), 0 descendants of its own

## Indications for use
The Tamarin Blue® RX PTCA 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/K112735
Methodology: https://510kreport.com/methodology