K110914 is an FDA 510(k) clearance for the TRIPLE LUMEN PFM 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 Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 21, 2011, 173 days after receiving the submission on April 1, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K110914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2011 |
| Decision Date | September 21, 2011 |
| Days to Decision | 173 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 |