Tlink Data Management System (DMS)
FDA 510(k) K113214 · Terumo Cardiovascular Systems Corp.
510(k) numberK113214
Submission
- Device name
- Tlink Data Management System (DMS)
- Applicant
- Terumo Cardiovascular Systems Corp.
Ann Arbor, MI, US - Received
- October 31, 2011
- Decision date
- February 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K172220 | Advanced Perfusion System 1DTQ · Special | 08/17/2017SE |
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| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | 11/17/2016SE |
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Questions and answers
When was Tlink Data Management System (DMS) cleared by the FDA?
Tlink Data Management System (DMS) (K113214) received a 510(k) decision of Substantially Equivalent on February 7, 2012, 99 days after the submission was received.
What is the product code of K113214?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.