FDA 510(k) Application Details - K182238

Device Classification Name

  More FDA Info for this Device
510(K) Number K182238
Device Name Reprocessed ViewFlex Xtra ICE Catheter
Applicant Stryker Sustainability Solutions
1810 West Drake Drive
Tempe, AZ 85283 US
Other 510(k) Applications for this Company
Contact Ramona Kulik
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 08/20/2018
Decision Date 05/08/2019
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