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FDA 510(k)

ACR 2500 CARDIOTOMY RESERVOIR FILTER

K-Number: K842391 · 1985-05-21

ApplicantElectromedics, Inc.
Decision Date1985-05-21
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACR 2500 CARDIOTOMY RESERVOIR FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K842391. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACR 2500 CARDIOTOMY RESERVOIR FILTER?

ACR 2500 CARDIOTOMY RESERVOIR FILTER is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Electromedics, Inc.. The 510(k) number is K842391.

When did ACR 2500 CARDIOTOMY RESERVOIR FILTER receive FDA 510(k) clearance?

ACR 2500 CARDIOTOMY RESERVOIR FILTER received FDA 510(k) clearance on 1985-05-21, under 510(k) number K842391.

Who is the listed applicant for ACR 2500 CARDIOTOMY RESERVOIR FILTER?

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

What is the FDA product code for ACR 2500 CARDIOTOMY RESERVOIR FILTER?

The FDA product code for ACR 2500 CARDIOTOMY RESERVOIR FILTER is DTN.

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Related Devices (Code: DTN)

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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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