The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Smartsite Needle Free Valve Administration Sets.
| Device ID | K061285 |
| 510k Number | K061285 |
| Device Name: | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613203012028 | K061285 | 000 |
| 40884389191003 | K061285 | 000 |