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FDA 510(k)

AUTOTRANSFUSION DEVICE

K-Number: K892819 · 1989-05-22

ApplicantImpra, Inc.
Decision Date1989-05-22
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOTRANSFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1989-05-22 under 510(k) number K892819. 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 AUTOTRANSFUSION DEVICE?

AUTOTRANSFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Impra, Inc.. The 510(k) number is K892819.

When did AUTOTRANSFUSION DEVICE receive FDA 510(k) clearance?

AUTOTRANSFUSION DEVICE received FDA 510(k) clearance on 1989-05-22, under 510(k) number K892819.

Who is the listed applicant for AUTOTRANSFUSION DEVICE?

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

What is the FDA product code for AUTOTRANSFUSION DEVICE?

The FDA product code for AUTOTRANSFUSION DEVICE is CAC.

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Other records listing Impra, Inc. as applicant

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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

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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