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FDA 510(k)

COBE HEMOFLO BLOOD TUBING SETS

K-Number: K801211 · 1980-07-14

ApplicantCobe Laboratories, Inc.
Decision Date1980-07-14
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE HEMOFLO 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 1980-07-14 under 510(k) number K801211. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE HEMOFLO BLOOD TUBING SETS?

COBE HEMOFLO BLOOD TUBING SETS is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K801211.

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

COBE HEMOFLO BLOOD TUBING SETS received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801211.

Who is the listed applicant for COBE HEMOFLO 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 COBE HEMOFLO BLOOD TUBING SETS?

The FDA product code for COBE HEMOFLO BLOOD TUBING SETS is FJK.

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Other records listing Cobe Laboratories, Inc. as applicant

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K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, 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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