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FDA 510(k)

VPI URETERAL DILATATION BALLON CATHETER

K-Number: K813278 · 1981-12-18

ApplicantVance Products, Inc.
Decision Date1981-12-18
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VPI URETERAL DILATATION BALLON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vance Products, Inc.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813278. 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 VPI URETERAL DILATATION BALLON CATHETER?

VPI URETERAL DILATATION BALLON CATHETER is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Vance Products, Inc.. The 510(k) number is K813278.

When did VPI URETERAL DILATATION BALLON CATHETER receive FDA 510(k) clearance?

VPI URETERAL DILATATION BALLON CATHETER received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813278.

Who is the listed applicant for VPI URETERAL DILATATION BALLON CATHETER?

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

What is the FDA product code for VPI URETERAL DILATATION BALLON CATHETER?

The FDA product code for VPI URETERAL DILATATION BALLON CATHETER is EZN.

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Other records listing Vance Products, 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.

K820313VPI-FAIR URETHRAL STENTK812995VANCE-JACOBELLIS MICROHEMATURIA CATHETERK812785VANCE-AMBROSE RESECTOSCOPE FORCEPSK812057VANCE CYSTOSCOPICK811833VNACE FASCIAL DILATOR SETK811454VANCE PROSTATIC ASPIRATION SET

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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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