The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Lumed Expando-cath, Activ.
| Device ID | K884806 |
| 510k Number | K884806 |
| Device Name: | LUMED EXPANDO-CATH, ACTIV |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Contact | Ronald B Luther |
| Correspondent | Ronald B Luther LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-17 |
| Decision Date | 1989-02-08 |