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510(k) K884354

IMAGER FLUSH CATHETERS by Medi-Tech, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1989
Date Received
October 17, 1988
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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  • K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS (June 1, 1995)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)

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