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FDA 510(k)

VAN-TEC ONE STEP URETERAL DILATATION CATHETER

K-Number: K870697 · 1987-03-10

ApplicantVan-Tec, Inc.
Decision Date1987-03-10
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC ONE STEP URETERAL DILATATION 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 1987-03-10 under 510(k) number K870697. 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 ONE STEP URETERAL DILATATION CATHETER?

VAN-TEC ONE STEP URETERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Van-Tec, Inc.. The 510(k) number is K870697.

When did VAN-TEC ONE STEP URETERAL DILATATION CATHETER receive FDA 510(k) clearance?

VAN-TEC ONE STEP URETERAL DILATATION CATHETER received FDA 510(k) clearance on 1987-03-10, under 510(k) number K870697.

Who is the listed applicant for VAN-TEC ONE STEP URETERAL DILATATION 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 VAN-TEC ONE STEP URETERAL DILATATION CATHETER?

The FDA product code for VAN-TEC ONE STEP URETERAL DILATATION CATHETER 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.

K880099VAN-TEC BLADDER EVACUATORK880095BERGER PROSTATE CULTURE CYTOLOGY BRUSHK880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUPK880098VAN-TEC AUTO BIOPSY NEEDLEK880094VAN-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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