K181904 is an FDA 510(k) clearance for the 5 FR Dual Lumen Piper PICC. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on September 25, 2018, 71 days after receiving the submission on July 16, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K181904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2018 |
| Decision Date | September 25, 2018 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |