MDRWeb Log-in
Username:
Password:
Remember Me
Subscribe

Search 510(k) Database | Monthly 510(k) Lists | Search PMA Database | Monthly PMA Lists


510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: CATHETER, SUBCUTANEOUS INTRAVASCULAR, IMPLANTED
Regulation Number: 880.5965
[See Other Products with this regulation number]
510(k) Number: K032600
Device Name: VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
Applicant: BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK

GLENS FALLS, NY 12801 3864
Contact: JODI LYNN GREENIZEN
Product Code: LJT
[See Other Manufacturers that make this Product]
Date Received: 08-25-2003
Decision Date: 09-09-2003
Decision: SE
Advisory Committee: HO
Statement/Summary/Purged Status: Summary
Type: Special
Review by Third Party: N
Expedited Review: N
Canon Communications medical device and pharmaceutical media network includes:
Qmed
Medical Device & Diagnostic Industry
Medical Product & Manufacturing News
European Medical Device Technology
China Medical Device Manufacturer
In Vitro Diagnostic Technology
Med Ad News
R&D Directions
PharmaLive.com
Pharmalot.com
eKnowledgebase
Pharmaceutical & Medical Packaging News
Packaging Digest