The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Safelet Catheter.
| Device ID | K895768 |
| 510k Number | K895768 |
| Device Name: | EXEL SAFELET CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Eshagh Hamid |
| Correspondent | Eshagh Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1990-02-16 |