FDA 510(k) Application Details - K220171

Device Classification Name	More FDA Info for this Device
510(K) Number	K220171
Device Name	NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Applicant	Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 US Other 510(k) Applications for this Company
Contact	Matthew Farley Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2022
Decision Date	07/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review