The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Intravascular Extension Set.
| Device ID | K210430 |
| 510k Number | K210430 |
| Device Name: | Intravascular Extension Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
| Contact | Meaghan Bonn |
| Correspondent | Meaghan Bonn Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-12 |
| Decision Date | 2021-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412639401 | K210430 | 000 |