The following data is part of a premarket notification filed by Clinical Plastic Products Sa with the FDA for Jet Port Plus Catheter System.
| Device ID | K000125 |
| 510k Number | K000125 |
| Device Name: | JET PORT PLUS CATHETER SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | CLINICAL PLASTIC PRODUCTS SA 154 VIA LAMPARA Rancho Santa Margarita, CA 92688 |
| Contact | Salvadore F Palomares |
| Correspondent | Salvadore F Palomares CLINICAL PLASTIC PRODUCTS SA 154 VIA LAMPARA Rancho Santa Margarita, CA 92688 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 76401109879888 | K000125 | 000 |
| 76401109879406 | K000125 | 000 |
| 76401109877426 | K000125 | 000 |
| 76401109877280 | K000125 | 000 |
| 76401109877044 | K000125 | 000 |
| 76401109876436 | K000125 | 000 |
| 76401109875132 | K000125 | 000 |
| 76401109875064 | K000125 | 000 |