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510(k) K061356

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 by Advanced Infusion, Inc. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2006
Date Received
May 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

Other clearances by Advanced Infusion, Inc.

  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K061661 — STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 (October 18, 2006)
  • K042246 — MULTI-DRIP INFUSION CATHETER (August 31, 2004)
  • K021964 — ALPHA INFUSION PUMP AND CATHETERS (August 12, 2002)
  • K992551 — ALPHA INFUSION PUMP (October 27, 1999)

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  • K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 7, 2021)
  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)