MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K992320
Device Name MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
5905 nathan ln.
plymouth, 
MN 
55442

Applicant Contact ronald w bennett
Correspondent
BOSTON SCIENTIFIC CORP.
5905 nathan ln.
plymouth, 
MN 
55442

Correspodent Contact ronald w bennett
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 07/12/1999
Decision Date 05/18/2000
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No