PLATO MICROCATH 27 MICROCATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K121734
Device Name PLATO MICROCATH 27 MICROCATHETER
Applicant
SCIENTIA VASCULAR , LLC
2700 south 900 west
suite d
salt lake city, 
UT 
84119

Applicant Contact sharon rockwell
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 06/13/2012
Decision Date 07/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No