The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Clave Vial Access Spike.
| Device ID | K934591 |
| 510k Number | K934591 |
| Device Name: | CLAVE VIAL ACCESS SPIKE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Salvadore F Palomares |
| Correspondent | Salvadore F Palomares ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-24 |
| Decision Date | 1994-02-16 |