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FDA 510(k)

VAN-TEC FASCIAL DILATOR

K-Number: K820865 · 1982-05-05

ApplicantVan-Tec, Inc.
Decision Date1982-05-05
Product CodeGCC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC FASCIAL 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 1982-05-05 under 510(k) number K820865. The device is classified under product code GCC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN-TEC FASCIAL DILATOR?

VAN-TEC FASCIAL DILATOR is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Van-Tec, Inc.. The 510(k) number is K820865.

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

VAN-TEC FASCIAL DILATOR received FDA 510(k) clearance on 1982-05-05, under 510(k) number K820865.

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

The FDA product code for VAN-TEC FASCIAL DILATOR is GCC.

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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: GCC)

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.

K981061INTRAVASCULAR RETRIEVAL DEVICEMed Institute, Inc.K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SETMed Institute, Inc.K902502BYRD STAINLESS STEEL DILATORMedical Engineering and Development InstituteK893480BYRD EXTRACTOR SETMedical Engineering and Development Institute

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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