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FDA 510(k)

AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER

K-Number: K940678 · 1994-04-15

ApplicantBaxter Healthcare Corp
Decision Date1994-04-15
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1994-04-15 under 510(k) number K940678. 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 SUCTION RESERVOIR WITH FILTER?

AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K940678.

When did AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER receive FDA 510(k) clearance?

AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER received FDA 510(k) clearance on 1994-04-15, under 510(k) number K940678.

Who is the listed applicant for AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER?

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

What is the FDA product code for AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER?

The FDA product code for AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER is CAC.

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Other records listing Baxter Healthcare Corp 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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