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510(k) K020733

PVS 1500 SDS by Precision Vascular Systems, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
March 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Precision Vascular Systems, Inc.

  • K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER (September 5, 2003)
  • K032146 — PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES (August 12, 2003)
  • K023700 — PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE (December 4, 2002)
  • K002907 — PVS 1300 NEURO GUIDE WIRE (March 8, 2001)
  • K002707 — PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING (November 8, 2000)
  • K990823 — PVS 1400 GUIDEWIRE (July 23, 1999)

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