Filao NC RX Ptca Dilatation Catheter
FDA 510(k) K141933 · Natec Medical , Ltd.
510(k) numberK141933
Submission
- Device name
- Filao NC RX Ptca Dilatation Catheter
- Applicant
- Natec Medical , Ltd.
Baltimore, MD, US - Received
- July 16, 2014
- Decision date
- June 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5100
- Specialty
- Cardiovascular
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Other 510(k)s with product code LOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 08/14/2026SE |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 07/27/2026SE |
| K252116 | Firefighter Pro PTCA Balloon CatheterLOX · Traditional | Shanghai MicroPort Medical (Group) Co., Ltd. | 04/07/2026SE |
| K254022 | FLASH Flex Aorto-Ostial Angioplasty SystemLOX · Traditional | Verge Medical, Inc. | 04/02/2026SE |
| K252295 | RyureiLOX · Traditional | Terumo Corporation | 03/27/2026SE |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | Medtronic, Ireland | 01/17/2026SE |
| K242969 | Pantera Pro; Pantera LEOLOX · Special | Biotronik, Inc. | 10/25/2024SE |
| K233499 | Sapphire NC ULTRA Coronary Dilatation CatheterLOX · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 08/16/2024SE |
| K233505 | Sapphire ULTRA Coronary Dilatation CatheterLOX · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 08/15/2024SE |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional | Vascular Solutions, LLC | 05/31/2024SE |
More from Vascular Solutions, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | 12/18/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | 12/18/2024SE |
| K220410 | Ebony HP PTA OTW 0.035 CatheterLIT · Traditional | 06/29/2022SE |
| K210012 | Tamarin Blue PTCA RX Dilatation CatheterLOX · Special | 07/09/2021SE |
| K152230 | Ebony PTA .014 RX Pheripheral Dilatation CatheterLIT · Special | 09/03/2015SE |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterLIT · Special | 06/04/2015SE |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation CatheterLIT · Traditional | 03/30/2015SE |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation CatheterLIT · Traditional | 02/03/2015SE |
| K112735 | Tamarin Blue Ptca RX Dilatation CatheterLOX · Traditional | 11/02/2012SE |
| K112513 | Ebony Pta 0.014 Peripheral Dilatation CatheterLIT · Traditional | 12/09/2011SE |
Questions and answers
When was Filao NC RX Ptca Dilatation Catheter cleared by the FDA?
Filao NC RX Ptca Dilatation Catheter (K141933) received a 510(k) decision of Substantially Equivalent on June 28, 2015, 347 days after the submission was received.
What is the product code of K141933?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.