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510(k) K251949

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK by Penumbra, Inc. — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2026
Date Received
June 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral Mechanical Thrombectomy With Aspiration
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

Other clearances by Penumbra, Inc.

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  • K250079 — Ruby XL System (March 14, 2025)
  • K242104 — Penumbra System (Reperfusion Catheter RED 72) (February 13, 2025)
  • K242033 — Access25™ Delivery Microcatheter (December 11, 2024)
  • K242520 — Element Vascular Access System (November 20, 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 QEW

  • K260028 — CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiec (February 5, 2026)
  • K253730 — RoVo Mechanical Thrombectomy System (January 21, 2026)
  • K251207 — Sangria™ Thrombectomy System (January 7, 2026)
  • K252956 — Helo Thrombectomy System (December 18, 2025)
  • K251070 — Akura Thrombectomy System (November 25, 2025)
  • K253323 — Protrieve Sheath (October 29, 2025)
  • K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, F (October 22, 2025)
  • K252612 — INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiratio (October 16, 2025)
  • K252057 — Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (August 28, 2025)
  • K251485 — Excipio LV Prime Thrombectomy Device (June 13, 2025)