The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Onecath, L-cath Catheter System, Model Oc-(16-22 Ga., 5cm-60cm).
| Device ID | K980090 |
| 510k Number | K980090 |
| Device Name: | ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 530 KINGS RD. Newport Beach, CA 92663 -5710 |
| Contact | Barbara C Luther |
| Correspondent | Barbara C Luther LUTHER MEDICAL PRODUCTS, INC. 530 KINGS RD. Newport Beach, CA 92663 -5710 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-03-24 |
| Summary: | summary |