Medical Device Manufacturer · US , Crofton , MD

Natec Medical , Ltd.

11 submissions · 11 cleared · Since 2011
11
Total
11
Cleared
0
Denied

Natec Medical , Ltd. — FDA 510(k) Submissions

Natec Medical , Ltd. has submitted 11 FDA 510(k) premarket notifications since 2011, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Angioplasty, Peripheral, Transluminal, Catheters, Transluminal Coronary Angioplasty, Percutaneous . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Amethyst HP PTA OTW 0.035 Catheter
K251915 · LIT Catheter, Angioplasty,... · Cardiovascular
Dec 2025 178d
Amethyst HP PTA OTW 0.035 Catheter
K241040 · LIT Catheter, Angioplasty,... · Cardiovascular
Dec 2024 246d
Ebony HP PTA OTW 0.035 Catheter
K220410 · LIT Catheter, Angioplasty,... · Cardiovascular
Jun 2022 135d
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · LOX Catheters, Transluminal... · Cardiovascular
Jul 2021 186d
FILAO NC RX PTCA DILATATION CATHETER
K141933 · LOX Catheters, Transluminal... · Cardiovascular
Jun 2015 347d
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
K143041 · LIT Catheter, Angioplasty,... · Cardiovascular
Jun 2015 225d
Ebony PTA 0.035 Peripheral Dilatation Catheter
K143036 · LIT Catheter, Angioplasty,... · Cardiovascular
Mar 2015 159d
Ebony PTA 0.014 RX Peripheral Dilatation Catheter
K142459 · LIT Catheter, Angioplasty,... · Cardiovascular
Feb 2015 154d
TAMARIN BLUE PTCA RX DILATATION CATHETER
K112735 · LOX Catheters, Transluminal... · Cardiovascular
Nov 2012 409d
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K112513 · LIT Catheter, Angioplasty,... · Cardiovascular
Dec 2011 101d
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
K103354 · LIT Catheter, Angioplasty,... · Cardiovascular
Feb 2011 99d
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