The following data is part of a premarket notification filed by Phoenix Biomedical with the FDA for Phoenix Infusion Catheter.
| Device ID | K033017 |
| 510k Number | K033017 |
| Device Name: | PHOENIX INFUSION CATHETER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL PO BOX 80390 2495 GENERAL ARMISTEAD AVE Valley Forge, PA 19484 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith PHOENIX BIOMEDICAL PO BOX 80390 2495 GENERAL ARMISTEAD AVE Valley Forge, PA 19484 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2004-04-07 |