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FDA 510(k)

SEPTISLEEVE

K-Number: K820883 · 1982-04-29

ApplicantArgon Medical Corp.
Decision Date1982-04-29
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEPTISLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Corp.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820883. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPTISLEEVE?

SEPTISLEEVE is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Argon Medical Corp.. The 510(k) number is K820883.

When did SEPTISLEEVE receive FDA 510(k) clearance?

SEPTISLEEVE received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820883.

Who is the listed applicant for SEPTISLEEVE?

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

What is the FDA product code for SEPTISLEEVE?

The FDA product code for SEPTISLEEVE is DYG.

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Other records listing Argon Medical Corp. as applicant

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Related Devices (Code: DYG)

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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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