The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Pfm Picc.
| Device ID | K072391 |
| 510k Number | K072391 |
| Device Name: | PFM PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2007-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813623013616 | K072391 | 000 |
| 20813623010189 | K072391 | 000 |
| 20813623010165 | K072391 | 000 |