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510(k) K140466

PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 by St. Jude Medical Systems AB — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
February 24, 2014
Clearance Type
Traditional
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 St. Jude Medical Systems AB

  • K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 (December 20, 2013)
  • K131452 — PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 (September 5, 2013)
  • K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER (October 21, 2011)
  • K110193 — FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEM (February 24, 2011)

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