Home / 510(k) Clearances / K251915

510(k) K251915

Amethyst HP PTA OTW 0.035 Catheter by Natec Medical , Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
June 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Natec Medical , Ltd.

  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
  • K220410 — Ebony HP PTA OTW 0.035 Catheter (June 29, 2022)
  • K210012 — Tamarin Blue PTCA RX Dilatation Catheter (July 9, 2021)
  • K152230 — Ebony PTA .014 RX Pheripheral Dilatation Catheter (September 3, 2015)
  • K141933 — FILAO NC RX PTCA DILATATION CATHETER (June 28, 2015)
  • K143041 — Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Cathe (June 4, 2015)
  • K143036 — Ebony PTA 0.035 Peripheral Dilatation Catheter (March 30, 2015)
  • K142459 — Ebony PTA 0.014 RX Peripheral Dilatation Catheter (February 3, 2015)
  • K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETER (November 2, 2012)
  • K112513 — EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER (December 9, 2011)

Other clearances for product code LIT

  • K252512 — Armada™ 14 NC PTA Catheter (February 13, 2026)
  • K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Ca (April 4, 2025)
  • K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon D (February 27, 2025)
  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
  • K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (November 15, 2024)
  • K241740 — Finesse Injectable™ PTA Balloon Dilatation Catheter (July 16, 2024)
  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K241683 — Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling (July 10, 2024)
  • K241025 — JADE PLUS PTA Balloon Dilatation Catheter (June 11, 2024)
  • K231402 — HP PTA Balloon Dilatation Catheter (December 20, 2023)