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510(k) K914979

EDM(R) INFUSION CATHETER by Peripheral Systems Group — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1992
Date Received
November 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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  • K931327 — PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE (July 14, 1993)
  • K915554 — HI-TORQUE SPORT-T(TM) GUIDE WIRE (February 9, 1993)
  • K913941 — PSG(TM) 20 GUAGE DOPPLER NEEDLE (February 27, 1992)
  • K915168 — PROFLEX 5 (February 19, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)
  • K913746 — SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM (December 17, 1991)
  • K904984 — ADVANCE 418(TM) (April 12, 1991)

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