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510(k) K915168

PROFLEX 5 by Peripheral Systems Group — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1992
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Peripheral Systems Group

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  • K931327 — PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE (July 14, 1993)
  • K915554 — HI-TORQUE SPORT-T(TM) GUIDE WIRE (February 9, 1993)
  • K914979 — EDM(R) INFUSION CATHETER (September 16, 1992)
  • K913941 — PSG(TM) 20 GUAGE DOPPLER NEEDLE (February 27, 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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