FDA 510(k) Application Details - DEN210024

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210024
Device Name	CavaClear Laser Sheath
Applicant	Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	Sondra Chandler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2021
Decision Date	12/21/2021
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review