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FDA 510(k)

DISPOSABLE HEMOSTATIC Y-CONNECTORS

K-Number: K113132 · 2012-01-20

ApplicantCoeur, Inc.
Decision Date2012-01-20
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEMOSTATIC Y-CONNECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Coeur, Inc.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K113132. 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 DISPOSABLE HEMOSTATIC Y-CONNECTORS?

DISPOSABLE HEMOSTATIC Y-CONNECTORS is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Coeur, Inc.. The 510(k) number is K113132.

When did DISPOSABLE HEMOSTATIC Y-CONNECTORS receive FDA 510(k) clearance?

DISPOSABLE HEMOSTATIC Y-CONNECTORS received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113132.

Who is the listed applicant for DISPOSABLE HEMOSTATIC Y-CONNECTORS?

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

What is the FDA product code for DISPOSABLE HEMOSTATIC Y-CONNECTORS?

The FDA product code for DISPOSABLE HEMOSTATIC Y-CONNECTORS is DTL.

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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.

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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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