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510(k) K092644

TERUMO PRESSURE ISOLATOR by Terumo Cardiovascular Systems Corp. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2009
Date Received
August 27, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by Terumo Cardiovascular Systems Corp.

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  • K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (March 13, 2013)
  • K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX (March 13, 2013)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) (February 7, 2012)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)

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