K122402 is an FDA 510(k) clearance for the LPP (LOW PROFILE PORT). This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 16, 2013, 343 days after receiving the submission on August 7, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K122402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2012 |
| Decision Date | July 16, 2013 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |