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510(k) K974175

HEARTPORT ENDOAORTIC CLAMP CATHETER by Heartport, Inc. — Product Code DWZ

K974175 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT ENDOAORTIC CLAMP CATHETER". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Heartport, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
November 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
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)
  • K972570 — HEARTPORT INTRODUCER SHEATH (October 1, 1997)
  • K971291 — HEARTPORT ENDOARTERIAL RETURN CANNULA (June 17, 1997)
  • K964302 — HEARTPORT THORACIC TROCAR (May 9, 1997)
  • K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SET (May 9, 1997)
  • K964161 — HEARTPORT ENDOAORTIC CLAMP (April 4, 1997)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K973818 — T-REX BIOPSY FORCEPS (December 16, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K933235 — CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (January 6, 1994)
  • K932788 — CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (September 1, 1993)

FDA data resources