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510(k) K121849

PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE by Care Fusion — Product Code DWM

K121849 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE". The FDA issued a decision of Substantially Equivalent on October 18, 2012. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Care Fusion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2012
Date Received
June 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

Other clearances by Care Fusion

  • K233021 — BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (March 6, 2024)
  • K231888 — BD Texium™ Needle-Free Syringe (September 25, 2023)
  • K221327 — BD Alaris™ Pump Infusion Sets (July 21, 2023)
  • K221319 — BD Alaris™ Pump Epidural Infusion Set (July 21, 2023)
  • K223101 — BD Secondary Infusion Set (May 12, 2023)
  • K223088 — BD SmartSite™ Needle-Free Connector (April 7, 2023)
  • K223076 — BD Texium™ Closed Male Luer (March 24, 2023)
  • K201155 — PleurX Peritoneal Catheter System (October 21, 2020)
  • K170405 — BD Curve Ascites Shunt (November 2, 2017)
  • K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Bio (September 11, 2017)

Other clearances for product code DWM

  • K212696 — Aspira Pleural Drainage System (March 3, 2023)
  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K201404 — Passio Pump Drainage System (November 20, 2020)
  • K190292 — Passio Pump Drainage System (July 25, 2019)
  • K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
  • K160450 — Pleurx Pleural Catheter System (October 31, 2016)
  • K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (July 2, 2015)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K112831 — PLEURX PLEURAL CATHETER SYSTEMS (February 16, 2012)
  • K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 11, 2011)

FDA data resources