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FDA 510(k)

FETH-R-KATH

K-Number: K981329 · 1998-08-26

ApplicantEpimed International, Inc.
Decision Date1998-08-26
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FETH-R-KATH is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International, Inc.. It received FDA 510(k) clearance on 1998-08-26 under 510(k) number K981329. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETH-R-KATH?

FETH-R-KATH is a medical device that received FDA 510(k) clearance on 1998-08-26. The listed applicant is Epimed International, Inc.. The 510(k) number is K981329.

When did FETH-R-KATH receive FDA 510(k) clearance?

FETH-R-KATH received FDA 510(k) clearance on 1998-08-26, under 510(k) number K981329.

Who is the listed applicant for FETH-R-KATH?

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

What is the FDA product code for FETH-R-KATH?

The FDA product code for FETH-R-KATH is BSO.

Other records listing Epimed International, 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: BSO)

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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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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