TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K002902
Device Name TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
Original Applicant
THE KENDALL COMPANY
15 hampshire st.
mansfield, 
MA 
02048

Original Contact frank j fucile
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 09/18/2000
Decision Date 04/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized