The following data is part of a premarket notification filed by Biocontrol Technology, Inc. with the FDA for Theraport Vascular Access System; Model 1001, 1002, 1601, 1602.
| Device ID | K960350 |
| 510k Number | K960350 |
| Device Name: | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 |
| 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 | 1996-01-25 |
| Decision Date | 1996-04-15 |
| Summary: | summary |