# Natec Medical, Ltd.

- Location (FDA's records): Reduit, MU
- FDA decisions: 12 (2011–2025): 12 510(k) clearances
- Names in FDA's records: Natec Medical , Ltd. (11); Natec Medical (1)
- Product codes: LIT (9), LOX (3)
- 510(k) review time since 2016: median 182 days, against 106 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 10 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic, Ireland: 2 (https://510kreport.com/company/medtronic-ireland)
- Abbott Vascular-Cardiac Therapies: 2 (https://510kreport.com/company/abbott-vascular-cardiac-therapies)
- Ev3, Inc.: 2 (https://510kreport.com/company/ev3)
- Invatec Innovative Technologies, S.R.L.: 2 (https://510kreport.com/company/invatec-innovative-technologies)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Scimed Life Systems, Inc.: 1 (https://510kreport.com/company/scimed-life-systems)
- Cordis Europa, N.V.: 1 (https://510kreport.com/company/cordis-europa)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Meril Life Sciences Private Limited: 1 (https://510kreport.com/company/meril-life-sciences-private)

## Its most-cited devices
- K112735: Tamarin Blue Ptca RX Dilatation Catheter (2012), cited by 3
- K112513: Ebony Pta 0.014 Peripheral Dilatation Catheter (2011), cited by 3
- K103354: Ebony Pta .035 Peripheral Dilatation Catheter (2011), cited by 2
- K142459: Ebony PTA 0.014 RX Peripheral Dilatation Catheter (2015), cited by 1
- K241040: Amethyst HP PTA OTW 0.035 Catheter (2024), cited by 1

## Recent decisions
- K251915: Amethyst HP PTA OTW 0.035 Catheter (Dec 18, 2025)
- K241040: Amethyst HP PTA OTW 0.035 Catheter (Dec 18, 2024)
- K220410: Ebony HP PTA OTW 0.035 Catheter (Jun 29, 2022)
- K210012: Tamarin Blue PTCA RX Dilatation Catheter (Jul 9, 2021)
- K152230: Ebony PTA .014 RX Pheripheral Dilatation Catheter (Sep 3, 2015)
- K141933: Filao NC RX Ptca Dilatation Catheter (Jun 28, 2015)
- K143041: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (Jun 4, 2015)
- K143036: Ebony PTA 0.035 Peripheral Dilatation Catheter (Mar 30, 2015)

Source page: https://510kreport.com/company/natec-medical