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 |