The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Clearlink System Solution Set.
| Device ID | K180739 |
| 510k Number | K180739 |
| Device Name: | Clearlink System Solution Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Jeanette Licata |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2019-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565748 | K180739 | 000 |
| 50085412565694 | K180739 | 000 |
| 50085412565687 | K180739 | 000 |
| 50085412676642 | K180739 | 000 |
| 50085412676635 | K180739 | 000 |
| 50085412676628 | K180739 | 000 |