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510(k) K081225

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM by Cardica, Inc. — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2008
Date Received
April 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE (February 25, 2014)
  • K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE (February 19, 2014)
  • K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAP (January 7, 2014)
  • K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 (June 25, 2010)
  • K091017 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 (April 29, 2009)
  • K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM (April 21, 2009)
  • K073304 — CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBL (December 20, 2007)
  • K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 (December 6, 2007)

Other clearances for product code FZP

  • K253781 — InnoClip Clip Applier (December 22, 2025)
  • K253903 — InnoClip Disposable Clip Applier (December 22, 2025)
  • K250643 — Disposable Polymer Ligation Clips (November 20, 2025)
  • K251054 — Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (July 3, 2025)
  • K242541 — GEM ZIPCLIP (January 15, 2025)
  • K221495 — SOLID CLIP™ Single Use Clip Applier (July 18, 2024)
  • K232970 — Hem-o-lok® Ligating Clips (January 12, 2024)
  • K230966 — angiOCCLUDE Ligating Clips (September 19, 2023)
  • K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endo (August 29, 2023)
  • K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (April 28, 2023)