Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
FDA 510(k) K143041 · Natec Medical , Ltd.
510(k) numberK143041
Submission
- Device name
- Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
- Applicant
- Natec Medical , Ltd.
Reduit, MU - Received
- October 22, 2014
- Decision date
- June 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 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 |
| K141933 | Filao NC RX Ptca Dilatation CatheterLOX · Traditional | 06/28/2015SE |
| 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 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter cleared by the FDA?
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (K143041) received a 510(k) decision of Substantially Equivalent on June 4, 2015, 225 days after the submission was received.
What is the product code of K143041?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.