PTS-X SIZING BALLOON CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K110903
Device Name PTS-X SIZING BALLOON CATHETER
Applicant
NUMED, INC.
2880 main st.
hopkinton, 
NY 
12965

Applicant Contact nichelle laflesh
Correspondent
NUMED, INC.
2880 main st.
hopkinton, 
NY 
12965

Correspodent Contact nichelle laflesh
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 03/31/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No