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-n Precision Introducer; Bd Introsyte Autoguard Shielded Introducer; Bd I.
| Device ID | K020834 |
| 510k Number | K020834 |
| Device Name: | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I |
| Classification | Introducer, Catheter |
| Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Laslie Wood |
| Correspondent | Laslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-14 |
| Decision Date | 2002-06-12 |
| Summary: | summary |