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510(k) K994243

DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP by Heartport, Inc. — Product Code DWF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 5, 2000
Date Received: December 16, 1999
Clearance Type: Special
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.

K981995 — QUICKDRAW VENOUS CANNULA (April 20, 1999)
K990772 — DIRECTFLOW ARTERIAL CANNULA (March 23, 1999)
K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER (September 4, 1998)
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)