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FDA 510(k)

KENSEY CATHETER

K-Number: K880194 · 1988-04-18

ApplicantTheratek, Inc.
Decision Date1988-04-18
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENSEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Theratek, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880194. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENSEY CATHETER?

KENSEY CATHETER is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Theratek, Inc.. The 510(k) number is K880194.

When did KENSEY CATHETER receive FDA 510(k) clearance?

KENSEY CATHETER received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880194.

Who is the listed applicant for KENSEY CATHETER?

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

What is the FDA product code for KENSEY CATHETER?

The FDA product code for KENSEY CATHETER is LIT.

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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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