FDA 510(k) Application Details - K002612

Device Classification Name Catheter, Retention Type, Balloon

  More FDA Info for this Device
510(K) Number K002612
Device Name Catheter, Retention Type, Balloon
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
Other 510(k) Applications for this Company
Contact GEORGIA C ABERNATHY
Other 510(k) Applications for this Contact
Regulation Number 876.5130

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

  More FDA Info for this Product Code
Date Received 08/21/2000
Decision Date 09/03/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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