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510(k) K970496

HEARTPORT MAZE SYSTEM: CRYOPROBE SET by Heartport, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
February 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

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)
  • K964302 — HEARTPORT THORACIC TROCAR (May 9, 1997)
  • K964161 — HEARTPORT ENDOAORTIC CLAMP (April 4, 1997)

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