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510(k) K991513

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO by I-Flow Corp. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1999
Date Received
April 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
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)
  • K023827 — PARAGON INFUSION SYSTEM WITH BOLUS (December 13, 2002)
  • K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS (October 18, 2002)

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