The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Universal Vial Access Spike.
| Device ID | K080989 |
| 510k Number | K080989 |
| Device Name: | UNIVERSAL VIAL ACCESS SPIKE |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709040509 | K080989 | 000 |
| 10840619053939 | K080989 | 000 |
| 10840619034259 | K080989 | 000 |
| 10840619026025 | K080989 | 000 |
| 10840619025837 | K080989 | 000 |
| 10840619025813 | K080989 | 000 |
| 10840619025783 | K080989 | 000 |
| 10840619025776 | K080989 | 000 |
| 10840619025752 | K080989 | 000 |
| 10840619023765 | K080989 | 000 |
| 10887709092560 | K080989 | 000 |
| 10840619056213 | K080989 | 000 |
| 10840619059511 | K080989 | 000 |
| 10840619054240 | K080989 | 000 |
| 10887709086552 | K080989 | 000 |
| 10887709058412 | K080989 | 000 |
| 10887709035741 | K080989 | 000 |
| 10887709035345 | K080989 | 000 |
| 10887709035321 | K080989 | 000 |
| 10887709035246 | K080989 | 000 |
| 10887709027371 | K080989 | 000 |
| 10840619078796 | K080989 | 000 |
| 10840619065703 | K080989 | 000 |
| 10840619098312 | K080989 | 000 |