FDA 510(k) Application Details - K031091

Device Classification Name Flowmeter, Blood, Cardiovascular

  More FDA Info for this Device
510(K) Number K031091
Device Name Flowmeter, Blood, Cardiovascular
Applicant VASCULAR TECHNOLOGY INCORPORATED
175 CABOT ST.
LOWELL, MA 01854 US
Other 510(k) Applications for this Company
Contact DAVID L REGAN
Other 510(k) Applications for this Contact
Regulation Number 870.2100

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

  More FDA Info for this Product Code
Date Received 04/07/2003
Decision Date 04/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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