K120150 is an FDA 510(k) clearance for the DUAL SPIKE TRANSFER DEVICE. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on May 24, 2012, 127 days after receiving the submission on January 18, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K120150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2012 |
| Decision Date | May 24, 2012 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |