The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Large Bore Stopcock With Rotating Male Luer Lock/large Bore Stopcock With Extension Set, Gang Large Bore Stopcock Manifo.
| Device ID | K130245 |
| 510k Number | K130245 |
| Device Name: | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO |
| Classification | Stopcock, I.v. Set |
| Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 -0490 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 -0490 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-31 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565649 | K130245 | 000 |
| 50085412032752 | K130245 | 000 |
| 50085412028939 | K130245 | 000 |
| 50085412017858 | K130245 | 000 |
| 50085412017711 | K130245 | 000 |
| 50085412003868 | K130245 | 000 |
| 50085412003851 | K130245 | 000 |
| 50085412002342 | K130245 | 000 |
| 50085412002182 | K130245 | 000 |
| 50085412045394 | K130245 | 000 |
| 50085412046308 | K130245 | 000 |
| 50085412476242 | K130245 | 000 |
| 50085412476228 | K130245 | 000 |
| 50085412476198 | K130245 | 000 |
| 50085412090127 | K130245 | 000 |
| 50085412076299 | K130245 | 000 |
| 50085412073687 | K130245 | 000 |
| 50085412071676 | K130245 | 000 |
| 50085412046315 | K130245 | 000 |
| 50085412001918 | K130245 | 000 |