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FDA 510(k)

VAN-TEC MEATAL DILATOR

K-Number: K851158 · 1985-04-15

ApplicantVan-Tec, Inc.
Decision Date1985-04-15
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC MEATAL DILATOR 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 1985-04-15 under 510(k) number K851158. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN-TEC MEATAL DILATOR?

VAN-TEC MEATAL DILATOR is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is Van-Tec, Inc.. The 510(k) number is K851158.

When did VAN-TEC MEATAL DILATOR receive FDA 510(k) clearance?

VAN-TEC MEATAL DILATOR received FDA 510(k) clearance on 1985-04-15, under 510(k) number K851158.

Who is the listed applicant for VAN-TEC MEATAL DILATOR?

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 MEATAL DILATOR?

The FDA product code for VAN-TEC MEATAL DILATOR is KOE.

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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: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.

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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