The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Jet Port Plus Hp Catheter System.
| Device ID | K072481 |
| 510k Number | K072481 |
| Device Name: | JET PORT PLUS HP CATHETER SYSTEM |
| 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 | 2007-09-04 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965451190 | K072481 | 000 |
| 07640110981283 | K072481 | 000 |
| 07640110981276 | K072481 | 000 |
| 07640110981788 | K072481 | 000 |
| 07640110981702 | K072481 | 000 |
| 07640110981757 | K072481 | 000 |
| 07640110982099 | K072481 | 000 |
| 07640110982174 | K072481 | 000 |
| 07640110982167 | K072481 | 000 |
| 07640110981931 | K072481 | 000 |
| 07640110981917 | K072481 | 000 |
| 07640110982075 | K072481 | 000 |
| 07640110980835 | K072481 | 000 |
| H965451250 | K072481 | 000 |
| H965451270 | K072481 | 000 |
| H965451280 | K072481 | 000 |
| H965451300 | K072481 | 000 |
| H965451170 | K072481 | 000 |
| H965451810 | K072481 | 000 |
| H965451820 | K072481 | 000 |
| H965451830 | K072481 | 000 |
| H965451840 | K072481 | 000 |
| 07640110982082 | K072481 | 000 |
| 07640110982198 | K072481 | 000 |
| 07640110982181 | K072481 | 000 |
| 76401109888934 | K072481 | 000 |
| 76401109889306 | K072481 | 000 |
| 76401109889542 | K072481 | 000 |
| 76401451102078 | K072481 | 000 |
| 76401451102146 | K072481 | 000 |
| 76401451102382 | K072481 | 000 |
| 76401451102450 | K072481 | 000 |
| 76401451102528 | K072481 | 000 |
| 76401451102696 | K072481 | 000 |
| 76401109888866 | K072481 | 000 |
| 76401109888798 | K072481 | 000 |
| 76401109888552 | K072481 | 000 |
| 07640110981801 | K072481 | 000 |
| 07640110981948 | K072481 | 000 |
| 07640110982006 | K072481 | 000 |
| 07640110981894 | K072481 | 000 |
| 07640110981993 | K072481 | 000 |
| 07640110981900 | K072481 | 000 |
| 07640110982068 | K072481 | 000 |
| 76401109854892 | K072481 | 000 |
| 76401109888170 | K072481 | 000 |
| 76401451102764 | K072481 | 000 |