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FDA 510(k)

COBE STOPCOCK

K-Number: K780271 · 1978-03-02

ApplicantCobe Laboratories, Inc.
Decision Date1978-03-02
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE STOPCOCK 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 1978-03-02 under 510(k) number K780271. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE STOPCOCK?

COBE STOPCOCK is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K780271.

When did COBE STOPCOCK receive FDA 510(k) clearance?

COBE STOPCOCK received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780271.

Who is the listed applicant for COBE STOPCOCK?

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 STOPCOCK?

The FDA product code for COBE STOPCOCK is DTL.

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Other records listing Cobe Laboratories, 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.

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: DTL)

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

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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