The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for T-port Hp Infusion Port.
| Device ID | K071993 |
| 510k Number | K071993 |
| Device Name: | T-PORT HP INFUSION PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-20 |
| Decision Date | 2007-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 76401109875378 | K071993 | 000 |
| 76401109874760 | K071993 | 000 |
| 76401109872544 | K071993 | 000 |
| 76401109872476 | K071993 | 000 |