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510(k) K961333

HEARTPORT MULTIFIRE CLIP APPLIER by Heartport, Inc. — Product Code DSS

K961333 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT MULTIFIRE CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Heartport, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1996
Date Received
April 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Vascular
Device Class
Class II
Regulation Number
870.3250
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)
  • K964302 — HEARTPORT THORACIC TROCAR (May 9, 1997)
  • K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SET (May 9, 1997)

Other clearances for product code DSS

  • K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM) (January 21, 1999)
  • K920104 — IDENTI LOOPS DEGANIA SILICONE (April 20, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 1992)
  • K901303 — HORIZON SURGICAL LIGATING AND MARKING CLIP (June 5, 1990)
  • K883909 — SURGICAL SPRING CLIPS (December 27, 1988)
  • K771021 — AUTO-CLIP (June 14, 1977)

FDA data resources