K130245 is an FDA 510(k) clearance for the LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 1, 2013, 29 days after receiving the submission on January 31, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K130245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2013 |
| Decision Date | March 01, 2013 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |