510(k) K082870

VTI INTRAOPERATIVE DOPPLER SYSTEMS by Vascular Technology Incorporated — Product Code DPW

K082870 is an FDA 510(k) premarket notification submitted by Vascular Technology Incorporated for the device "VTI INTRAOPERATIVE DOPPLER SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 28, 2008. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Vascular Technology Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2008
Date Received
September 29, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type