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FDA 510(k)

VAN-TEC GUIDE WIRE W/HYDROMER COATING

K-Number: K851160 · 1985-07-29

ApplicantVan-Tec, Inc.
Decision Date1985-07-29
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC GUIDE WIRE W/HYDROMER COATING 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 1985-07-29 under 510(k) number K851160. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN-TEC GUIDE WIRE W/HYDROMER COATING?

VAN-TEC GUIDE WIRE W/HYDROMER COATING is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Van-Tec, Inc.. The 510(k) number is K851160.

When did VAN-TEC GUIDE WIRE W/HYDROMER COATING receive FDA 510(k) clearance?

VAN-TEC GUIDE WIRE W/HYDROMER COATING received FDA 510(k) clearance on 1985-07-29, under 510(k) number K851160.

Who is the listed applicant for VAN-TEC GUIDE WIRE W/HYDROMER COATING?

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 GUIDE WIRE W/HYDROMER COATING?

The FDA product code for VAN-TEC GUIDE WIRE W/HYDROMER COATING is KOD.

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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: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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