K083873 is an FDA 510(k) clearance for the PICC (CT RATED AND NON-RATED). This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Pfm Medical, Inc. (Oceanside, US). The FDA issued a Cleared decision on March 19, 2009, 80 days after receiving the submission on December 29, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K083873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2008 |
| Decision Date | March 19, 2009 |
| Days to Decision | 80 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 |