ACUITY UNIVERSAL CUTTER


Device Classification Name

catheter, percutaneous

510(k) Number K080154
Device Name ACUITY UNIVERSAL CUTTER
Applicant
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Applicant Contact kathleen vittum
Correspondent
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Correspodent Contact kathleen vittum
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 01/23/2008
Decision Date 03/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No