NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER


Device Classification Name

catheter, nephrostomy

510(k) Number K121614
Device Name NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact lauren anderson
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact lauren anderson
Classification Product Code
LJE  
Date Received 06/01/2012
Decision Date 09/18/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls