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510(k) K091017

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 by Cardica, Inc. — Product Code FZP

K091017 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001". The FDA issued a decision of Substantially Equivalent on April 29, 2009. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Cardica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2009
Date Received
April 9, 2009
Clearance Type
Special
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

Other clearances by Cardica, Inc.

  • K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip R (July 20, 2016)
  • K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutt (January 15, 2016)
  • 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)
  • K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM (April 21, 2009)
  • K081225 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (September 5, 2008)
  • 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

  • K260677 — Vessel Closure Device (VCD177213P) (September 17, 2026)
  • K254231 — Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Cli (July 20, 2026)
  • 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)

FDA data resources