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510(k) K020655

DELTEC INSULIN INFUSION PUMP AND ACCESSORIES by Deltec, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2002
Date Received
March 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Deltec, Inc.

  • K031361 — CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP (May 23, 2003)
  • K030983 — TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X (April 25, 2003)
  • K022221 — TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS (January 30, 2003)
  • K021999 — GRIPPER PLUS NEEDLE (August 13, 2002)

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  • K210714 — Extended Reservoir (April 6, 2022)
  • K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (August 13, 2021)
  • K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (October 21, 2019)
  • K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (January 8, 2019)
  • K180045 — Omnipod DASH Insulin Management System (June 1, 2018)
  • K162296 — OmniPod Insulin Management System (April 18, 2017)
  • K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up (October 25, 2016)