MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS


Device Classification Name

catheter, percutaneous

510(k) Number K030589
Device Name MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
Applicant
NUMED, INC.
2880 main st.
hopkinton, 
NY 
12965

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

Correspodent Contact nichelle r laflesh
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 02/25/2003
Decision Date 05/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No