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510(k) K913746

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM by Peripheral Systems Group — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
August 21, 1991
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

Other clearances by Peripheral Systems Group

  • K940804 — SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION (June 10, 1994)
  • K934433 — VANTAGE DIALTAION CATHETER (December 9, 1993)
  • K932777 — SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER (October 7, 1993)
  • 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)
  • K915168 — PROFLEX 5 (February 19, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)
  • K904984 — ADVANCE 418(TM) (April 12, 1991)

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