Home / 510(k) Clearances / K881197

510(k) K881197

SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER by Schneider-Shilley (Usa) — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1988
Date Received
March 21, 1988
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 Schneider-Shilley (Usa)

  • K882826 — SOFTRAC-PTA PERIPHERAL DILATATION CATHETER (January 24, 1989)
  • K875175 — MODIFIED PERIPHERAL DILATATION CATHETERS (July 28, 1988)
  • K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (March 28, 1988)
  • K875323 — MODIFIED SCHNEIDER-SHILEY WIRE TORQUER (March 28, 1988)
  • K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (March 25, 1988)
  • K875324 — MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES (March 25, 1988)
  • K875326 — MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER (February 18, 1988)
  • K875325 — MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK (February 18, 1988)

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)