Home / 510(k) Clearances / K933050

510(k) K933050

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH by Critikon Company, LLC — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1993
Date Received
May 20, 1993
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 Critikon Company, LLC

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  • K982342 — DINAMAP MPS SELECT PORTABLE MONITOR (August 14, 1998)
  • K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR (June 16, 1995)
  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K912188 — DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 (December 4, 1991)

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