The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Insyte Autoguard Bc.
| Device ID | K110443 |
| 510k Number | K110443 |
| Device Name: | BD INSYTE AUTOGUARD BC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BECTON DICKINSON & CO. 9450 SOUTH STATE STREET Sandy, UT 84070 |
| Contact | Rand Pugmire |
| Correspondent | Rand Pugmire BECTON DICKINSON & CO. 9450 SOUTH STATE STREET Sandy, UT 84070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903826570 | K110443 | 000 |
| 50382903825238 | K110443 | 000 |
| 50382903825337 | K110443 | 000 |
| 50382903825344 | K110443 | 000 |
| 50382903825375 | K110443 | 000 |
| 50382903825443 | K110443 | 000 |
| 50382903825474 | K110443 | 000 |
| 50382903825542 | K110443 | 000 |
| 50382903825573 | K110443 | 000 |
| 50382903826129 | K110443 | 000 |
| 50382903826235 | K110443 | 000 |
| 50382903826334 | K110443 | 000 |
| 50382903826341 | K110443 | 000 |
| 50382903826372 | K110443 | 000 |
| 50382903826440 | K110443 | 000 |
| 50382903826471 | K110443 | 000 |
| 50382903826549 | K110443 | 000 |
| 50382903825122 | K110443 | 000 |