The following data is part of a premarket notification filed by Icu Medical with the FDA for Sapphire Sets.
| Device ID | K171346 |
| 510k Number | K171346 |
| Device Name: | Sapphire Sets |
| Classification | Accessories, Pump, Infusion |
| Applicant | ICU Medical 600 N. Field Drive Lake Forest, IL 60045 |
| Contact | Andrea Doyle |
| Correspondent | Amy Giertych ICU Medical 600 N. Field Drive Lake Forest, IL 60045 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887787009266 | K171346 | 000 |
| 20887787007422 | K171346 | 000 |
| 20887787007415 | K171346 | 000 |
| 20887787007408 | K171346 | 000 |
| 20887787007392 | K171346 | 000 |
| 20887787007361 | K171346 | 000 |
| 20887787007354 | K171346 | 000 |
| 20887787007316 | K171346 | 000 |
| 20887787007309 | K171346 | 000 |
| 20887787007279 | K171346 | 000 |
| 20887787007439 | K171346 | 000 |
| 20887787007446 | K171346 | 000 |
| 20887787009259 | K171346 | 000 |
| 20887787009242 | K171346 | 000 |
| 20887787007552 | K171346 | 000 |
| 20887787007538 | K171346 | 000 |
| 20887787007521 | K171346 | 000 |
| 20887787007514 | K171346 | 000 |
| 20887787007491 | K171346 | 000 |
| 20887787007484 | K171346 | 000 |
| 20887787007477 | K171346 | 000 |
| 20887787007262 | K171346 | 000 |