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FDA 510(k)

EPC FILTER

K-Number: K813123 · 1981-11-27

Decision Date1981-11-27
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPC FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K813123. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPC FILTER?

EPC FILTER is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K813123.

When did EPC FILTER receive FDA 510(k) clearance?

EPC FILTER received FDA 510(k) clearance on 1981-11-27, under 510(k) number K813123.

Who is the listed applicant for EPC FILTER?

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

What is the FDA product code for EPC FILTER?

The FDA product code for EPC FILTER is DRR.

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.

Other records listing Codman & Shurtleff, 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: DRR)

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.

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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