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510(k) K231828

Pounce™ Sheath by Surmodics,Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2023
Date Received
June 21, 2023
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 Surmodics,Inc.

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  • K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135) (September 11, 2024)
  • K232647 — Microcatheter (September 29, 2023)
  • K231022 — Pounce™ Thrombectomy System (June 12, 2023)
  • K221886 — Sublime Microcatheter (October 14, 2022)
  • K220501 — Pounce Thrombectomy System (March 23, 2022)
  • K211492 — Pounce Thrombectomy System (July 30, 2021)
  • K192814 — Pounce Thrombus Retrieval System (September 21, 2020)
  • K190644 — Guide Sheath (April 18, 2019)
  • K173560 — Microcatheter (January 12, 2018)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • 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)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)