K153605 is an FDA 510(k) clearance for the ivWatch Model 400. This device is classified as a Peripheral Intravenous (piv) Infiltration Monitor (Class II - Special Controls, product code PMS).
Submitted by Ivwatch, LLC (Williamsburg, US). The FDA issued a Cleared decision on February 11, 2016, 56 days after receiving the submission on December 17, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations..
| 510(k) Number | K153605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2015 |
| Decision Date | February 11, 2016 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PMS - Peripheral Intravenous (piv) Infiltration Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations. |