The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Antimicrobial Clave, Models Ag Clave, Ag Microclave.
| Device ID | K090189 |
| 510k Number | K090189 |
| Device Name: | ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-26 |
| Decision Date | 2009-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709050522 | K090189 | 000 |