BIB PTA BALLOON CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal, dual-balloon

510(k) Number K050857
Device Name BIB PTA BALLOON CATHETER
Applicant
NUMED, INC.
2880 main st.
hopkinton, 
NY 
12965

Applicant Contact jodi gijanto
Correspondent
NUMED, INC.
2880 main st.
hopkinton, 
NY 
12965

Correspodent Contact jodi gijanto
Regulation Number 870.1250
Classification Product Code
NVM  
Date Received 04/05/2005
Decision Date 07/28/2005
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No