The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Safe-cath.
| Device ID | K960764 |
| 510k Number | K960764 |
| Device Name: | SAFE-CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Contact | Richard C Bell |
| Correspondent | Richard C Bell SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1997-04-24 |
| Summary: | summary |