The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Heparin Lock Flush Syring 10 Usp Units/ml, Heparin Lock Flush Syringe, 100 Usp Units/ml.
| Device ID | K003245 |
| 510k Number | K003245 |
| Device Name: | HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Linda Coleman |
| Correspondent | Linda Coleman BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2000-12-04 |