Home / 510(k) Clearances / K242520

510(k) K242520

Element Vascular Access System by Penumbra, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2024
Date Received
August 23, 2024
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 Penumbra, Inc.

  • K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (February 5, 2026)
  • K252612 — INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiratio (October 16, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242104 — Penumbra System (Reperfusion Catheter RED 72) (February 13, 2025)
  • K242033 — Access25™ Delivery Microcatheter (December 11, 2024)
  • K242075 — Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (September 25, 2024)
  • 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)
  • K240030 — Indigo® Aspiration System - Lightning® Flash (February 2, 2024)

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)