The following data is part of a premarket notification filed by Infusion Devices, Inc. with the FDA for Intravascular Administration Set.
| Device ID | K003854 |
| 510k Number | K003854 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | INFUSION DEVICES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden INFUSION DEVICES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816336022268 | K003854 | 000 |
| 20816336022258 | K003854 | 000 |
| 20816336022487 | K003854 | 000 |