NHANCER


Device Classification Name

catheter, percutaneous

510(k) Number K121077
Device Name NHANCER
Applicant
IMDS OPERATIONS B.V.
ceinturrbaan noord 150
p.o. box 234
roden, drenthe, 

NL

9301 nz

Applicant Contact e schulting
Correspondent
IMDS OPERATIONS B.V.
ceinturrbaan noord 150
p.o. box 234
roden, drenthe, 

NL

9301 nz

Correspodent Contact e schulting
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 04/09/2012
Decision Date 12/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No