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510(k) K221655

Multiflex Steerable Sheath by Vizaramed, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2022
Date Received
June 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Vizaramed, Inc.

  • K260626 — Multiflex Steerable Sheath 17.5F (March 26, 2026)

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  • K260459 — VANES Delivery System (VDS) (April 6, 2026)
  • K260626 — Multiflex Steerable Sheath 17.5F (March 26, 2026)
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  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)