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FDA 510(k)

COLIGN

K-Number: K131124 · 2013-08-28

ApplicantJilin Coronado Medical , Ltd.
Decision Date2013-08-28
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COLIGN is the device name listed in this FDA 510(k) record. The listed applicant is Jilin Coronado Medical , Ltd.. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K131124. 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 COLIGN?

COLIGN is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Jilin Coronado Medical , Ltd.. The 510(k) number is K131124.

When did COLIGN receive FDA 510(k) clearance?

COLIGN received FDA 510(k) clearance on 2013-08-28, under 510(k) number K131124.

Who is the listed applicant for COLIGN?

The FDA 510(k) record lists Jilin Coronado Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLIGN?

The FDA product code for COLIGN is DTL.

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 Jilin Coronado Medical , Ltd. 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.

K131411COSEAL

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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.

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 LimitedK113845TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACEMedtronic, 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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