FDA 510(k) Application Details - K162522

Device Classification Name Catheter, Conduction, Anesthetic

  More FDA Info for this Device
510(K) Number K162522
Device Name Catheter, Conduction, Anesthetic
Applicant TELEFLEX MEDICAL , INC.
3015 Carrington Mill Blvd
Morrisville, NC 27560 US
Other 510(k) Applications for this Company
Contact James A. Cochie
Other 510(k) Applications for this Contact
Regulation Number 868.5120

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

  More FDA Info for this Product Code
Date Received 09/09/2016
Decision Date 03/17/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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