The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel With Pasv Port.
| Device ID | K030083 |
| 510k Number | K030083 |
| Device Name: | VAXCEL WITH PASV PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BOSTON SCIENTIFIC CORP. 10 GLENS FALLS TECHNICAL PARK Glens Falls, NY 12801 -3864 |
| Contact | Jodi Lynn Greenizen |
| Correspondent | Jodi Lynn Greenizen BOSTON SCIENTIFIC CORP. 10 GLENS FALLS TECHNICAL PARK Glens Falls, NY 12801 -3864 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-09 |
| Decision Date | 2003-01-28 |
| Summary: | summary |