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FDA 510(k)

AMSURE RED RUBBER URETHRAL CATHETER

K-Number: K030293 · 2004-02-04

ApplicantAmsino International, Inc.
Decision Date2004-02-04
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSURE RED RUBBER URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K030293. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSURE RED RUBBER URETHRAL CATHETER?

AMSURE RED RUBBER URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Amsino International, Inc.. The 510(k) number is K030293.

When did AMSURE RED RUBBER URETHRAL CATHETER receive FDA 510(k) clearance?

AMSURE RED RUBBER URETHRAL CATHETER received FDA 510(k) clearance on 2004-02-04, under 510(k) number K030293.

Who is the listed applicant for AMSURE RED RUBBER URETHRAL CATHETER?

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

What is the FDA product code for AMSURE RED RUBBER URETHRAL CATHETER?

The FDA product code for AMSURE RED RUBBER URETHRAL CATHETER is EYB.

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Other records listing Amsino International, Inc. as applicant

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Related Devices (Code: EYB)

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.

K192183RocaTub Ureteral CatheterPromepal SamK191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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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