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510(k) K893546

OPTICALLY CLEAR RADIOPAQUE CATHETER by Critikon Company, LLC — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1989
Date Received
May 11, 1989
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

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  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K933050 — CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (December 14, 1993)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)

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