510(k) Report

Devices descending from K990829

21 later devices reach Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies20043—
+1K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+1K030504Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060Idev Technologies, Inc.20031—
+1K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical2003131
+1K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc.200111Class I
+2K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+2K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+2K052428Resolution Endovascular SystemOmnisonics Medical Technologies20052—
+2K041374Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060Idev Technologies, Inc.20050—
+2K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+3K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+3K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+3K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+4K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+4K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+5K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+5K223891Cobra Catheter SystemEndovascular Engineering20232—
+6K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+7K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—