FDA 510(k) Application Details - K220331

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K220331
Device Name Catheter, Percutaneous
Applicant InNeuroCo Inc.
19700 Stirling Road, Suite 1
Pembroke Pines, FL 33332 US
Other 510(k) Applications for this Company
Contact Marc Litzenberg
Other 510(k) Applications for this Contact
Regulation Number 870.1250

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

  More FDA Info for this Product Code
Date Received 02/04/2022
Decision Date 07/29/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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