The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Lpp (low Profile Port).
| Device ID | K122402 |
| 510k Number | K122402 |
| Device Name: | LPP (LOW PROFILE PORT) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 Carlsbad, CA 92008 |
| Contact | Salvadore Palomares, Rac |
| Correspondent | Salvadore Palomares, Rac PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 Carlsbad, CA 92008 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-07 |
| Decision Date | 2013-07-16 |
| Summary: | summary |