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510(k) K230284

Penumbra LP Coil System by Penumbra, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2023
Date Received
February 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

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  • K242520 — Element Vascular Access System (November 20, 2024)
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  • K242319 — Indigo® Aspiration System – Aspiration Catheter 6X (September 3, 2024)
  • K241399 — Indigo® Lightning Flash Aspiration System – Select +™ Catheter (June 10, 2024)
  • K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Cathet (March 27, 2024)

Other clearances for product code HCG

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • K252694 — Target Detachable Coil (December 11, 2025)
  • K251832 — InZone IST Detachment System; IZDS Connecting Cable (October 17, 2025)
  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K242154 — Numen™ Coil Embolization System; NumenFR™ Detachment System (September 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K242243 — Target Detachable Coils (August 29, 2024)
  • K232955 — Numen Coil Embolization System; NumenFR Detachment System (January 10, 2024)
  • K233420 — Axium Detachable Coil; Axium Prime Detachable Coil (November 7, 2023)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)