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510(k) K844840

DESERET INTRODUCER SET by Parke-Davis Co. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1985
Date Received
December 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Parke-Davis Co.

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  • 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)
  • K850505 — DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER (March 11, 1985)

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