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510(k) K241207

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) by Devoro Medical, Inc. — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2024
Date Received
April 30, 2024
Clearance Type
Special
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 Devoro Medical, Inc.

  • K221391 — WOLF Thrombectomy™ SmartClaw Catheter (November 10, 2022)
  • K210911 — WOLF Thrombectomy System, 14F (October 19, 2021)
  • K210530 — WOLF Thrombectomy System, 6F (August 27, 2021)
  • K200101 — WOLF Thrombectomy V System (April 27, 2020)

Other clearances for product code QEW

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  • K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (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)