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FDA 510(k)

PERCUCATH URINARY CATHETER

K-Number: K090262 · 2009-05-28

ApplicantPercuvision, LLC
Decision Date2009-05-28
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUCATH URINARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Percuvision, LLC. It received FDA 510(k) clearance on 2009-05-28 under 510(k) number K090262. 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 PERCUCATH URINARY CATHETER?

PERCUCATH URINARY CATHETER is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is Percuvision, LLC. The 510(k) number is K090262.

When did PERCUCATH URINARY CATHETER receive FDA 510(k) clearance?

PERCUCATH URINARY CATHETER received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090262.

Who is the listed applicant for PERCUCATH URINARY CATHETER?

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

What is the FDA product code for PERCUCATH URINARY CATHETER?

The FDA product code for PERCUCATH URINARY CATHETER is EZL.

Related Clinical Trials

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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Other records listing Percuvision, LLC 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.

K091600DIRECTVISION GUIDE SYSTEM

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

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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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