The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Graduated Adapter With Clave.
| Device ID | K080007 |
| 510k Number | K080007 |
| Device Name: | GRADUATED ADAPTER WITH CLAVE |
| Classification | Catheter, Straight |
| Applicant | ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Contact | Tracy Best |
| Correspondent | Tracy Best ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2008-05-13 |
| Summary: | summary |