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510(k) K840671

CARDIAC CATHETERIZATION PACK by Professional Medical Services — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
February 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Professional Medical Services

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  • K904508 — CONDOR ANALOG INFLATION SYRINGE (April 2, 1991)
  • K904954 — CONDOR DIGITAL INFLATION SYRINGE (January 16, 1991)
  • K902606 — RADIOPAQUE RULER (September 27, 1990)
  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
  • K890471 — PMS ANGIO DRAPE (February 27, 1989)
  • K884497 — CONTROL SYRINGE (December 12, 1988)
  • K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
  • K864555 — 3 RING ATTACHMENT (December 1, 1986)

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