FDA 510(k) Application Details - K190212

Device Classification Name Catheter, Thrombus Retriever

  More FDA Info for this Device
510(K) Number K190212
Device Name Catheter, Thrombus Retriever
Applicant Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact Shazia Hakim
Other 510(k) Applications for this Contact
Regulation Number 870.1250

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

  More FDA Info for this Product Code
Date Received 02/04/2019
Decision Date 04/24/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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