The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Intravascular Extension Sets And Accessories.
| Device ID | K192366 |
| 510k Number | K192366 |
| Device Name: | Intravascular Extension Sets And Accessories |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Gary Chumbimune |
| Correspondent | Gary Chumbimune Baxter Healthcare Corporation 32650 N. Wilson Road 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 | 2019-08-30 |
| Decision Date | 2020-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412639395 | K192366 | 000 |
| 50085412639333 | K192366 | 000 |
| 50085412639357 | K192366 | 000 |
| 50085412638831 | K192366 | 000 |
| 50085412638848 | K192366 | 000 |
| 50085412639340 | K192366 | 000 |
| 50085412639418 | K192366 | 000 |
| 50085412639425 | K192366 | 000 |
| 50085412639449 | K192366 | 000 |
| 50085412653285 | K192366 | 000 |
| 50085412653292 | K192366 | 000 |
| 50085412660382 | K192366 | 000 |
| 50085412639364 | K192366 | 000 |
| 50085412639388 | K192366 | 000 |
| 50085412639326 | K192366 | 000 |