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510(k) K012948

Device
MODIFICATION TO VAXCEL DIALYSIS CATHETER
Applicant
Boston Scientific/Medi-Tech
510(k) number
K012948
Product code
MSD
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-03
Date received
2001-09-04
Regulation
876.5540
Classification name
Catheter, Hemodialysis, Implanted
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
NICHOLAS CONDAKES
Address
One Boston Scientific Pl. Natick, MA US 01760 01760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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