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FDA 510(k)

CONTIDRAIN CATHETER

K-Number: K964757 · 1997-06-25

ApplicantContimed, Inc.
Decision Date1997-06-25
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTIDRAIN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Contimed, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K964757. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTIDRAIN CATHETER?

CONTIDRAIN CATHETER is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Contimed, Inc.. The 510(k) number is K964757.

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

CONTIDRAIN CATHETER received FDA 510(k) clearance on 1997-06-25, under 510(k) number K964757.

Who is the listed applicant for CONTIDRAIN CATHETER?

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

What is the FDA product code for CONTIDRAIN CATHETER?

The FDA product code for CONTIDRAIN CATHETER is EZL.

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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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