Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k) K251915 · Natec Medical , Ltd.
510(k) numberK251915
Submission
- Device name
- Amethyst HP PTA OTW 0.035 Catheter
- Applicant
- Natec Medical , Ltd.
Moka, MU - Received
- June 23, 2025
- Decision date
- December 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K241025 | JADE PLUS PTA Balloon Dilatation CatheterLIT · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 06/11/2024SE |
More from OrbusNeich Medical (Shenzhen) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 Amethyst HP PTA OTW 0.035 Catheter cleared by the FDA?
Amethyst HP PTA OTW 0.035 Catheter (K251915) received a 510(k) decision of Substantially Equivalent on December 18, 2025, 178 days after the submission was received.
What is the product code of K251915?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.