FDA 510(k) Application Details - K241207

Device Classification Name	More FDA Info for this Device
510(K) Number	K241207
Device Name	SmartClawÖ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClawÖ Thrombectomy Catheter, 32 mm (FD0660-02)
Applicant	DeVoro Medical, Inc. 10700 Bren Rd W Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Aaron Lynch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2024
Decision Date	05/29/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review