The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Bd Introsyte Precision Introducer, Bd Introsyte Autogaurd Shielded Introducer.
| Device ID | K013304 |
| 510k Number | K013304 |
| Device Name: | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER |
| Classification | Fab, Rhodamine, Antigen, Antiserum, Control |
| Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Leslie Wood |
| Correspondent | Leslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | DBY |
| CFR Regulation Number | 866.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-04 |
| Decision Date | 2002-01-02 |
| Summary: | summary |