The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for L-cath Catheter System - Port L-cath.
| Device ID | K942103 |
| 510k Number | K942103 |
| Device Name: | L-CATH CATHETER SYSTEM - PORT L-CATH |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Contact | Barbara C Luther |
| Correspondent | Barbara C Luther LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-02 |
| Decision Date | 1994-07-26 |