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510(k) K031662

PRESSURE WIRE SENSOR, MODELS 12004/12304 by Radi Medical Systems AB — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2003
Date Received
May 28, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

Other clearances by Radi Medical Systems AB

  • K123984 — QUANTIEN MEASUREMENT SYSTEM (March 28, 2013)
  • K092105 — RADIANALYZER XPRESS (October 9, 2009)
  • K080813 — PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (July 1, 2008)
  • K080206 — MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (February 26, 2008)
  • K062769 — PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (December 4, 2006)
  • K042628 — MODIFICATION TO: RADIANALYZER, MODEL 12711 (January 19, 2005)
  • K033291 — TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (March 17, 2004)
  • K024107 — FEMOSTOP FEMORAL COMPRESSION SYSTEM (December 24, 2002)
  • K022188 — RADIANALYZER, MODEL 12710 (October 3, 2002)
  • K022187 — PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 (September 24, 2002)

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