The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel Impantable Vascular Access System.
| Device ID | K982888 |
| 510k Number | K982888 |
| Device Name: | VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Christine M Harris |
| Correspondent | Christine M Harris BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-10-20 |
| Summary: | summary |