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FDA 510(k)

GAMBRO VENOUS BLOOD LINE

K-Number: K770691 · 1977-04-28

ApplicantGambro, Inc.
Decision Date1977-04-28
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO VENOUS BLOOD LINE is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1977-04-28 under 510(k) number K770691. 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 GAMBRO VENOUS BLOOD LINE?

GAMBRO VENOUS BLOOD LINE is a medical device that received FDA 510(k) clearance on 1977-04-28. The listed applicant is Gambro, Inc.. The 510(k) number is K770691.

When did GAMBRO VENOUS BLOOD LINE receive FDA 510(k) clearance?

GAMBRO VENOUS BLOOD LINE received FDA 510(k) clearance on 1977-04-28, under 510(k) number K770691.

Who is the listed applicant for GAMBRO VENOUS BLOOD LINE?

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

What is the FDA product code for GAMBRO VENOUS BLOOD LINE?

The FDA product code for GAMBRO VENOUS BLOOD LINE is KOC.

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Other records listing Gambro, 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.

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Related Devices (Code: KOC)

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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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