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510(k) K023827

PARAGON INFUSION SYSTEM WITH BOLUS by I-Flow Corp. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2002
Date Received
November 18, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by I-Flow Corp.

  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K063530 — ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, (January 26, 2007)
  • K063234 — ON-Q INTRODUCERS (November 21, 2006)
  • K051401 — ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (November 30, 2005)
  • K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (September 9, 2005)
  • K043456 — MODIFICATION TO SOAKER CATHETER (January 11, 2005)
  • K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) (May 24, 2004)
  • K023883 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO (December 20, 2002)
  • K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS (October 18, 2002)
  • K022869 — SOAKER CATHETER (September 20, 2002)

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