Cardica, Inc.
Cardica, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2016, with 2 FDA device recalls on record.
Top product codes for Cardica, Inc.
FDA recalls by Cardica, Inc.
- Z-0483-2016 — MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.
- Z-0482-2016 — MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cardica, Inc.
- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
- K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
- K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
- K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
- K091017 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
- K090872 — MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
- K081225 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
- K073304 — CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
- K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
- K070548 — C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
- K063644 — CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
- K053524 — C-PORT DISTAL ANASTOMOSIS SYSTEM
- K040832 — C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
Data sourced from openFDA. This site is unofficial and independent of the FDA.