Home / 510(k) Clearances / K063563

510(k) K063563

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER by Cordis Europa, N.V. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2007
Date Received
November 28, 2006
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 Cordis Europa, N.V.

  • K071189 — CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER (May 16, 2007)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K040413 — CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (June 21, 2004)
  • K032737 — CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON (October 2, 2003)
  • K012056 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (August 1, 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)