The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Dual Lumen L-cath Catheter System.
| Device ID | K925979 |
| 510k Number | K925979 |
| Device Name: | DUAL LUMEN L-CATH CATHETER SYSTEM |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-05-27 |