The following data is part of a premarket notification filed by Biosphere Medical with the FDA for Biosphere Medical Infusion Catheter.
| Device ID | K003105 |
| 510k Number | K003105 |
| Device Name: | BIOSPHERE MEDICAL INFUSION CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOSPHERE MEDICAL 1050 HINGHAM ST. Rockland, MA 02370 |
| Contact | John Bonasera |
| Correspondent | John Bonasera BIOSPHERE MEDICAL 1050 HINGHAM ST. Rockland, MA 02370 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-04 |
| Decision Date | 2001-05-22 |