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FDA 510(k)

FLU-VEN TK-2

K-Number: K791130 · 1979-09-04

ApplicantVenospital, Inc.
Decision Date1979-09-04
Product CodeKSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLU-VEN TK-2 is the device name listed in this FDA 510(k) record. The listed applicant is Venospital, Inc.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791130. The device is classified under product code KSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLU-VEN TK-2?

FLU-VEN TK-2 is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Venospital, Inc.. The 510(k) number is K791130.

When did FLU-VEN TK-2 receive FDA 510(k) clearance?

FLU-VEN TK-2 received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791130.

Who is the listed applicant for FLU-VEN TK-2?

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

What is the FDA product code for FLU-VEN TK-2?

The FDA product code for FLU-VEN TK-2 is KSB.

Other records listing Venospital, 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.

K791131FLU VEN TR-1K790077BIOSTIL # 3884K790424FLU-VEN 01510K781186INFUSION, VENOTHIN 23K781184INFUSION SET, VENOTHIN 19K781190INFUSION SET, VENOTHIN 21

View all 14 devices →

Related Devices (Code: KSB)

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.

K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.K001043KAWASUMI LABORATORY BLOOD DRAWING KITKawasumi Laboratories America, Inc.K820447ALPHA PLASMA TRANSFER SETAlpha Therapeutic Corp.K802940SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.K791131FLU VEN TR-1Venospital, Inc.

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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