The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Icu Medical Universal Single-use Spikes.
| Device ID | K082836 |
| 510k Number | K082836 |
| Device Name: | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES |
| Classification | Stopcock, I.v. Set |
| Applicant | ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123 |
| Contact | Niloufar Samimi |
| Correspondent | Niloufar Samimi ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2009-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709041551 | K082836 | 000 |
| 10887709120157 | K082836 | 000 |
| 10887709120140 | K082836 | 000 |
| 10887709120133 | K082836 | 000 |
| 10887709079585 | K082836 | 000 |
| 10887709035338 | K082836 | 000 |
| 10887709035253 | K082836 | 000 |
| 10887709025049 | K082836 | 000 |
| 10840619078178 | K082836 | 000 |
| 10840619006027 | K082836 | 000 |
| 10840619005952 | K082836 | 000 |
| 10840619025981 | K082836 | 000 |
| 10840619026018 | K082836 | 000 |
| 10887709019468 | K082836 | 000 |
| 10887709018911 | K082836 | 000 |
| 10887709018737 | K082836 | 000 |
| 10887709018720 | K082836 | 000 |
| 10887709018645 | K082836 | 000 |
| 10887709018607 | K082836 | 000 |
| 10840619023888 | K082836 | 000 |
| 10840619084605 | K082836 | 000 |
| 10840619084599 | K082836 | 000 |
| 10840619053205 | K082836 | 000 |
| 10887709042237 | K082836 | 000 |