QEW — Peripheral Mechanical Thrombectomy With Aspiration

21 CFR 870.5150

Class 2

Definition

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

Medical Specialty

CV

Review Panel

CV

Submission Type

1

Target Area

Peripheral vasculature

Physical State

Peripheral catheter

Technical Method

Remove thrombus from peripheral vasculature

FDA Authorisations (140)

Device Name K-Number
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK K251949
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister K260028
RoVo Mechanical Thrombectomy System K253730
Sangria™ Thrombectomy System K251207
Helo Thrombectomy System K252956
Akura Thrombectomy System K251070
Protrieve Sheath K253323
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) K251185
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing K252612
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System K252057
Excipio LV Prime Thrombectomy Device K251485
Aventus Thrombectomy System K251189
Liberant Thrombectomy System K250787
Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System K250775
InThrill™ Thrombectomy System K250421
Aventus Thrombectomy System (IM-2100) K250668
FlowTriever2 Catheter K250088
Aventus Thrombectomy System K250202
Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath K241894
ClotTriever XL Catheter (41-102) K242557
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