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FDA 510(k)

VAN-TEC URETERAL DILATION BALLOON CATH

K-Number: K841940 · 1984-08-03

ApplicantVan-Tec, Inc.
Decision Date1984-08-03
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC URETERAL DILATION BALLOON CATH 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 1984-08-03 under 510(k) number K841940. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN-TEC URETERAL DILATION BALLOON CATH?

VAN-TEC URETERAL DILATION BALLOON CATH is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Van-Tec, Inc.. The 510(k) number is K841940.

When did VAN-TEC URETERAL DILATION BALLOON CATH receive FDA 510(k) clearance?

VAN-TEC URETERAL DILATION BALLOON CATH received FDA 510(k) clearance on 1984-08-03, under 510(k) number K841940.

Who is the listed applicant for VAN-TEC URETERAL DILATION BALLOON CATH?

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 VAN-TEC URETERAL DILATION BALLOON CATH?

The FDA product code for VAN-TEC URETERAL DILATION BALLOON CATH is EZN.

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Other records listing Van-Tec, Inc. 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.

K880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUPK880095BERGER PROSTATE CULTURE CYTOLOGY BRUSHK880098VAN-TEC AUTO BIOPSY NEEDLEK880099VAN-TEC BLADDER EVACUATORK880094VAN-TEC ENDOPYELOTOMY KNIFEK874112VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

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Related Devices (Code: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook 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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