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510(k) K981009

HEARTPORT ENDOPULMONARY VENT CATHETER by Heartport, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
March 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Heartport, Inc.

  • K994243 — DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TI (May 5, 2000)
  • K981995 — QUICKDRAW VENOUS CANNULA (April 20, 1999)
  • K990772 — DIRECTFLOW ARTERIAL CANNULA (March 23, 1999)
  • K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (July 15, 1998)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K972570 — HEARTPORT INTRODUCER SHEATH (October 1, 1997)
  • K971291 — HEARTPORT ENDOARTERIAL RETURN CANNULA (June 17, 1997)
  • K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SET (May 9, 1997)
  • K964302 — HEARTPORT THORACIC TROCAR (May 9, 1997)
  • K964161 — HEARTPORT ENDOAORTIC CLAMP (April 4, 1997)

Other clearances for product code DWF

  • K250937 — Venous Return Cannulae (March 11, 2026)
  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (February 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)