Home / 510(k) Clearances / K020854

510(k) K020854

MODIFICATION TO FOX PTA CATHETER by Jomed AG — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2002
Date Received
March 15, 2002
Clearance Type
Special
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 Jomed AG

  • K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (June 23, 2003)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M (May 14, 2003)
  • K030053 — JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015S (March 31, 2003)
  • K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG14 (December 16, 2002)
  • K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM (May 17, 2002)
  • K010838 — FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A1400 (June 21, 2001)
  • K003938 — TRAK BACK II (January 18, 2001)

Other clearances for product code LIT

  • K252512 — Armada™ 14 NC PTA Catheter (February 13, 2026)
  • K251915 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2025)
  • 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)