The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink System Lever Lock Cannula With Check Valve, Secondary Medication Sets, Solution Sets, Continu-flo Solution Set.
| Device ID | K123868 |
| 510k Number | K123868 |
| Device Name: | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Contact | Gary Chumbimune |
| Correspondent | Gary Chumbimune BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412068669 | K123868 | 000 |
| 50085412000546 | K123868 | 000 |
| 50085412002113 | K123868 | 000 |
| 50085412002120 | K123868 | 000 |
| 50085412002199 | K123868 | 000 |
| 50085412002243 | K123868 | 000 |
| 50085412002250 | K123868 | 000 |
| 50085412002267 | K123868 | 000 |
| 50085412002571 | K123868 | 000 |
| 50085412002588 | K123868 | 000 |
| 50085412004353 | K123868 | 000 |
| 50085412045752 | K123868 | 000 |
| 50085412068195 | K123868 | 000 |
| 50085412000522 | K123868 | 000 |