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510(k) K861725

INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT by Parke-Davis Co. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Parke-Davis Co.

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  • K855120 — ATI DISPOSABLE BIOLOGICAL TEST PACK (June 18, 1986)
  • K860570 — ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE (March 31, 1986)
  • K860290 — VIAPIC CENTRAL LINE CATHETER (March 18, 1986)
  • K852192 — DISPOSABLE STEAM BIOLOGICAL TEST PACK (November 1, 1985)
  • K841967 — DESERET THERMODILUTION CARDIAC OUTPUT (August 19, 1985)
  • K851327 — DESERET ARTERIAL CATHETER (June 14, 1985)
  • K852078 — SPECTRUM(TENTATIVE) (June 7, 1985)
  • K844840 — DESERET INTRODUCER SET (May 16, 1985)
  • K850505 — DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER (March 11, 1985)

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