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510(k) K230637

Wattson temporary pacing guidewire (2250) by Vascular Solutions, LLC — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2023
Date Received
March 7, 2023
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

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  • K193119 — Twin-Pass Dual Access Catheter (June 29, 2020)
  • K200720 — D-Stat Radial Topical Hemostat (June 26, 2020)
  • K192454 — Wattson Temporary Pacing Guidewire (January 15, 2020)
  • K191560 — Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP (August 9, 2019)

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