PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101


Device Classification Name

catheter, percutaneous

510(k) Number K023548
Device Name PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
Original Applicant
VELOCIMED
11400 73rd avenue north
suite 134
maple grove, 
MN 
55369

Original Contact john carline
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 10/22/2002
Decision Date 08/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No