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FDA 510(k)

OPEN ENDED URETERAL CATHETER

K-Number: K830840 · 1983-04-06

ApplicantVan-Tec, Inc.
Decision Date1983-04-06
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPEN ENDED URETERAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Van-Tec, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830840. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPEN ENDED URETERAL CATHETER?

OPEN ENDED URETERAL CATHETER is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Van-Tec, Inc.. The 510(k) number is K830840.

When did OPEN ENDED URETERAL CATHETER receive FDA 510(k) clearance?

OPEN ENDED URETERAL CATHETER received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830840.

Who is the listed applicant for OPEN ENDED URETERAL CATHETER?

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

What is the FDA product code for OPEN ENDED URETERAL CATHETER?

The FDA product code for OPEN ENDED URETERAL CATHETER is GBM.

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Other records listing Van-Tec, Inc. as applicant

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Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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