The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxess Peripherally Inserted Central Catheter.
| Device ID | K980566 |
| 510k Number | K980566 |
| Device Name: | VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Wanda M Carpinella |
| Correspondent | Wanda M Carpinella BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-13 |
| Decision Date | 1998-09-14 |
| Summary: | summary |