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510(k) K830637

VERTEX DIGITAL SUBSTRATION KIT by Professional Medical Services — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • 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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