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510(k) K080813

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER by Radi Medical Systems AB — Product Code DXO

K080813 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER". The FDA issued a decision of Substantially Equivalent on July 1, 2008. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2008
Date Received
March 21, 2008
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 Radi Medical Systems AB

  • K123984 — QUANTIEN MEASUREMENT SYSTEM (March 28, 2013)
  • K092105 — RADIANALYZER XPRESS (October 9, 2009)
  • 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)
  • K031662 — PRESSURE WIRE SENSOR, MODELS 12004/12304 (June 6, 2003)
  • 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)

Other clearances for product code DXO

  • K251367 — OptoMonitor 3 (January 16, 2026)
  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • K222216 — TruWave Disposable Pressure Transducer (December 22, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K193279 — Comet II Pressure Guidewire (December 23, 2019)
  • K192340 — OptoMonitor (December 12, 2019)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)

FDA data resources