The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Clearlink Antimicrobial Luer Activated Device (lad) And Extension Sets With The Clearlink Antimicrobial Luer Activated.
| Device ID | K072576 |
| 510k Number | K072576 |
| Device Name: | CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. MPGR-AL Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. MPGR-AL Mcgaw Park, IL 60085 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2007-11-06 |
| Summary: | summary |