K071222 is an FDA 510(k) clearance for the INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 25, 2007, 23 days after receiving the submission on May 2, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K071222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2007 |
| Decision Date | May 25, 2007 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |