The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Triple Lumen Pfm Picc.
| Device ID | K110914 |
| 510k Number | K110914 |
| Device Name: | TRIPLE LUMEN PFM PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PFM MEDICAL, INC 1815 ASTON AVE SUITE 106 Carlsbad, CA 92008 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares PFM MEDICAL, INC 1815 ASTON AVE SUITE 106 Carlsbad, CA 92008 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-01 |
| Decision Date | 2011-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813623040582 | K110914 | 000 |
| 20813623013791 | K110914 | 000 |
| 20813623013807 | K110914 | 000 |
| 20813623013814 | K110914 | 000 |
| 20813623013821 | K110914 | 000 |
| 20813623013838 | K110914 | 000 |
| 20813623017447 | K110914 | 000 |
| 00813623018075 | K110914 | 000 |
| 20813623018086 | K110914 | 000 |
| 20813623018093 | K110914 | 000 |
| 20813623018598 | K110914 | 000 |
| 20813623013784 | K110914 | 000 |