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FDA 510(k)

DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM

K-Number: K940519 · 1995-01-19

ApplicantDideco
Decision Date1995-01-19
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dideco. It received FDA 510(k) clearance on 1995-01-19 under 510(k) number K940519. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM?

DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-19. The listed applicant is Dideco. The 510(k) number is K940519.

When did DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1995-01-19, under 510(k) number K940519.

Who is the listed applicant for DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM?

The FDA product code for DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM is CAC.

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.

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Other records listing Dideco 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.

K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATORK010478DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SURK001388DATA MASTER PERFUSION MONITORING SYSTEMK936220DIDECO VACUUM PUMP

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

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

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