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510(k) K032146

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES by Precision Vascular Systems, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2003
Date Received
July 14, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Precision Vascular Systems, Inc.

  • K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER (September 5, 2003)
  • K023700 — PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE (December 4, 2002)
  • K020733 — PVS 1500 SDS (March 21, 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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