The following data is part of a premarket notification filed by Interrad Medical, Inc. with the FDA for Securacath Universal.
| Device ID | K092306 |
| 510k Number | K092306 |
| Device Name: | SECURACATH UNIVERSAL |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | INTERRAD MEDICAL, INC. 555 13TH STREET NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan INTERRAD MEDICAL, INC. 555 13TH STREET NW Washington, DC 20004 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2010-07-09 |
| Summary: | summary |