The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Irri-cath.
| Device ID | K833908 |
| 510k Number | K833908 |
| Device Name: | IRRI-CATH |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | PORTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1984-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IRRI-CATH 73495054 1336487 Live/Registered |
Portex, Inc. 1984-08-15 |