The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Intravascular Administration Sets.
| Device ID | K203609 |
| 510k Number | K203609 |
| Device Name: | Intravascular Administration Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
| Contact | Jeffrey E. Thompson |
| Correspondent | Jeffrey E. Thompson 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 | 2020-12-10 |
| Decision Date | 2021-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412071102 | K203609 | 000 |
| 50085412074424 | K203609 | 000 |
| 50085412071119 | K203609 | 000 |
| 50085412068386 | K203609 | 000 |
| 50085412049101 | K203609 | 000 |
| 50085412048548 | K203609 | 000 |
| 50085412031854 | K203609 | 000 |
| 50085412021152 | K203609 | 000 |
| 50085412014314 | K203609 | 000 |
| 51978860004367 | K203609 | 000 |
| 51978860004350 | K203609 | 000 |
| 50197886004361 | K203609 | 000 |
| 50085412077449 | K203609 | 000 |
| 50085412486517 | K203609 | 000 |
| 50085412653636 | K203609 | 000 |
| 50085412051708 | K203609 | 000 |
| 50085412049064 | K203609 | 000 |
| 50085412048999 | K203609 | 000 |
| 50085412048982 | K203609 | 000 |
| 50085412048975 | K203609 | 000 |
| 50085412048470 | K203609 | 000 |
| 50085412031793 | K203609 | 000 |
| 50085412020599 | K203609 | 000 |
| 50085412003943 | K203609 | 000 |
| 50085412002144 | K203609 | 000 |
| 50085412002137 | K203609 | 000 |
| 50197886004354 | K203609 | 000 |