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510(k) K182337

HYBRID Guidewire by Balt USA, LLC — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2018
Date Received
August 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K242376 — Next Generation Access Platform (December 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K234074 — Next Generation Access Catheter (July 2, 2024)
  • K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (July 2, 2024)
  • K230609 — NG Delivery Catheter (September 13, 2023)

Other clearances for product code MOF

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  • K253168 — 0.014” Willow Guidewire (November 26, 2025)
  • K244061 — X-Wire Guidewire (August 26, 2025)
  • K243756 — 0.014” Willow Guidewire (July 17, 2025)
  • K243383 — CHIKAI Nexus 014 (April 21, 2025)
  • K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir (April 1, 2025)
  • K240871 — Synxess Neurovascular Guidewire (November 18, 2024)
  • K233791 — Drivewire 24 Guidewire (July 11, 2024)
  • K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire (August 1, 2023)