The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Regulated Pressure Injector.
| Device ID | K860806 |
| 510k Number | K860806 |
| Device Name: | REGULATED PRESSURE INJECTOR |
| Classification | Catheter, Septostomy |
| Applicant | TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
| Contact | Marie Daniels |
| Correspondent | Marie Daniels TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
| Product Code | DXF |
| CFR Regulation Number | 870.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-03-31 |