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FDA 510(k)

HEMAFLO BLOOD TUBING SETS

K-Number: K823092 · 1982-11-22

ApplicantCobe Laboratories, Inc.
Decision Date1982-11-22
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMAFLO BLOOD TUBING SETS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823092. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAFLO BLOOD TUBING SETS?

HEMAFLO BLOOD TUBING SETS is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K823092.

When did HEMAFLO BLOOD TUBING SETS receive FDA 510(k) clearance?

HEMAFLO BLOOD TUBING SETS received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823092.

Who is the listed applicant for HEMAFLO BLOOD TUBING SETS?

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

What is the FDA product code for HEMAFLO BLOOD TUBING SETS?

The FDA product code for HEMAFLO BLOOD TUBING SETS is FKQ.

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Other records listing Cobe Laboratories, Inc. as applicant

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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