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510(k) K962858

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM by Heartport, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
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)
  • 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)

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  • K230281 — PICOCLAMP (October 23, 2023)
  • K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (March 3, 2023)
  • K230248 — VIOLA (February 28, 2023)
  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K210681 — SiteSeal SV (April 6, 2021)