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FDA 510(k)

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

K-Number: K081225 · 2008-09-05

ApplicantCardica, Inc.
Decision Date2008-09-05
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081225. 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 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM?

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Cardica, Inc.. The 510(k) number is K081225.

When did CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM receive FDA 510(k) clearance?

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081225.

Who is the listed applicant for CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM?

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 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM?

The FDA product code for CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM is FZP.

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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.

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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.

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