Home / 510(k) Clearances / K002907

510(k) K002907

PVS 1300 NEURO GUIDE WIRE by Precision Vascular Systems, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
September 18, 2000
Clearance Type
Traditional
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)
  • 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)
  • K020733 — PVS 1500 SDS (March 21, 2002)
  • K002707 — PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING (November 8, 2000)
  • K990823 — PVS 1400 GUIDEWIRE (July 23, 1999)

Other clearances for product code DQX

  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)