The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Modification To: T-port Hp Infusion Port.
| Device ID | K073210 |
| 510k Number | K073210 |
| Device Name: | MODIFICATION TO: 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-14 |
| Decision Date | 2007-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 76401109884592 | K073210 | 000 |
| 07640110981795 | K073210 | 000 |
| 07640110981597 | K073210 | 000 |
| 07640110981924 | K073210 | 000 |
| H965451300 | K073210 | 000 |
| H965451280 | K073210 | 000 |
| H965451270 | K073210 | 000 |
| H965451250 | K073210 | 000 |
| H965451190 | K073210 | 000 |
| H965451170 | K073210 | 000 |
| H965451130 | K073210 | 000 |
| H965451120 | K073210 | 000 |
| H965451110 | K073210 | 000 |
| H965451090 | K073210 | 000 |
| H965451030 | K073210 | 000 |
| 07640110981696 | K073210 | 000 |
| 07640110981603 | K073210 | 000 |
| 76401109884356 | K073210 | 000 |
| 76401109884110 | K073210 | 000 |
| 76401109883984 | K073210 | 000 |
| 76401109883748 | K073210 | 000 |
| 76401109883502 | K073210 | 000 |
| 76401109883366 | K073210 | 000 |
| 76401109854960 | K073210 | 000 |
| 07640110982136 | K073210 | 000 |
| 07640110980842 | K073210 | 000 |
| 07640110982150 | K073210 | 000 |
| 07640110982143 | K073210 | 000 |
| 07640110982112 | K073210 | 000 |
| 07640110982105 | K073210 | 000 |
| 07640110982129 | K073210 | 000 |
| H965451010 | K073210 | 000 |