Home / 510(k) Clearances / K914500

510(k) K914500

OPTI-PLAST 5F PTA CATHETERS, MODIFICATION by Vas-Cath, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1991
Date Received
October 8, 1991
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 Vas-Cath, Inc.

  • K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (June 19, 1998)
  • K965178 — NIAGARA DUAL LUMEN CATHETER (August 19, 1997)
  • K964881 — ULTRAVERSE PTA CATHETER (May 28, 1997)
  • K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER (May 9, 1997)
  • K941706 — OPTI-PLAST ANGIOPLASTY CATHETER (October 18, 1994)
  • K925485 — VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (March 10, 1994)
  • K933483 — OPTI-PLAST 5F PTA CATHETERS (September 24, 1993)
  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914976 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (January 27, 1992)

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)