FDA 510(k) Application Details - K221661

Device Classification Name Clamp, Vascular

  More FDA Info for this Device
510(K) Number K221661
Device Name Clamp, Vascular
Applicant Compression Works Inc
1634-A Montgomery Hwy #115
Hoover, AL 35216 US
Other 510(k) Applications for this Company
Contact John Croushorn
Other 510(k) Applications for this Contact
Regulation Number 870.4450

  More FDA Info for this Regulation Number
Classification Product Code DXC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/08/2022
Decision Date 03/03/2023
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact