The following data is part of a premarket notification filed by Biocontrol Technology, Inc. with the FDA for Theraport Low-profile Vascular Access System Models 1011 And 1012.
| Device ID | K974475 |
| 510k Number | K974475 |
| Device Name: | THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BIOCONTROL TECHNOLOGY, INC. 300 INDIAN SPRINGS RD. P.O. BOX 434 Indiana, PA 15701 |
| Contact | Patrick J Cooper |
| Correspondent | Patrick J Cooper BIOCONTROL TECHNOLOGY, INC. 300 INDIAN SPRINGS RD. P.O. BOX 434 Indiana, PA 15701 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-03-02 |
| Summary: | summary |