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FDA 510(k)

DRAINAGE CATHETER OR FOLEY CATHETER

K-Number: K010006 · 2001-07-25

ApplicantApplied Medical Resources Corp.
Decision Date2001-07-25
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE CATHETER OR FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2001-07-25 under 510(k) number K010006. 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 DRAINAGE CATHETER OR FOLEY CATHETER?

DRAINAGE CATHETER OR FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 2001-07-25. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K010006.

When did DRAINAGE CATHETER OR FOLEY CATHETER receive FDA 510(k) clearance?

DRAINAGE CATHETER OR FOLEY CATHETER received FDA 510(k) clearance on 2001-07-25, under 510(k) number K010006.

Who is the listed applicant for DRAINAGE CATHETER OR FOLEY CATHETER?

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

What is the FDA product code for DRAINAGE CATHETER OR FOLEY CATHETER?

The FDA product code for DRAINAGE CATHETER OR FOLEY CATHETER is EZL.

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Related Devices (Code: EZL)

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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