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FDA 510(k)

TLINK DATA MANAGEMENT SYSTEM (DMS)

K-Number: K113214 · 2012-02-07

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2012-02-07
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TLINK DATA MANAGEMENT SYSTEM (DMS) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2012-02-07 under 510(k) number K113214. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TLINK DATA MANAGEMENT SYSTEM (DMS)?

TLINK DATA MANAGEMENT SYSTEM (DMS) is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K113214.

When did TLINK DATA MANAGEMENT SYSTEM (DMS) receive FDA 510(k) clearance?

TLINK DATA MANAGEMENT SYSTEM (DMS) received FDA 510(k) clearance on 2012-02-07, under 510(k) number K113214.

Who is the listed applicant for TLINK DATA MANAGEMENT SYSTEM (DMS)?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TLINK DATA MANAGEMENT SYSTEM (DMS)?

The FDA product code for TLINK DATA MANAGEMENT SYSTEM (DMS) is DXJ.

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Related Devices (Code: DXJ)

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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