K053405 is an FDA 510(k) clearance for the BACSTOP. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on May 11, 2006, 155 days after receiving the submission on December 7, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K053405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2005 |
| Decision Date | May 11, 2006 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| 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 |