Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100

K-Number: K101018 · 2010-06-25

ApplicantCardica, Inc.
Decision Date2010-06-25
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K101018. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100?

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Cardica, Inc.. The 510(k) number is K101018.

When did CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 receive FDA 510(k) clearance?

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 received FDA 510(k) clearance on 2010-06-25, under 510(k) number K101018.

Who is the listed applicant for CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100?

The FDA 510(k) record lists Cardica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100?

The FDA product code for CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 is FZP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardica, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadK151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White CartridgeK091017CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001K090872MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMK081225CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEMK073304CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES

View all 12 devices →

Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑