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510(k) K964001

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM by Med Institute, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1998
Date Received
October 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K971140 — VITAL-PORT INFUSION PAL (November 17, 1997)
  • K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (April 30, 1997)
  • K945586 — FLEXIBLE DILATING SHEATH (April 4, 1997)
  • K960698 — NON-CORING NEEDLE (April 15, 1996)
  • K941228 — ENDOLUMINAL ACCESS TUBE (September 27, 1995)
  • K951077 — VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (July 31, 1995)
  • K951076 — VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM (June 13, 1995)

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  • K231783 — VitroPRO (November 14, 2023)