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FDA 510(k)

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD

K-Number: K902588 · 1991-03-07

ApplicantGambro-Hospal, Inc.
Decision Date1991-03-07
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD is the device name listed in this FDA 510(k) record. The listed applicant is Gambro-Hospal, Inc.. It received FDA 510(k) clearance on 1991-03-07 under 510(k) number K902588. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD?

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is Gambro-Hospal, Inc.. The 510(k) number is K902588.

When did BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD receive FDA 510(k) clearance?

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD received FDA 510(k) clearance on 1991-03-07, under 510(k) number K902588.

Who is the listed applicant for BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD?

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

What is the FDA product code for BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD?

The FDA product code for BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD is KOC.

Related Clinical Trials

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.

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Other records listing Gambro-Hospal, 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.

K896068TIPSTOP(TM)K901368HEMOSPAL KITS A1, A2D, AO, & A1D

Related Devices (Code: KOC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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