The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Spinning Spiros, Model Ch-2000.
| Device ID | K082806 |
| 510k Number | K082806 |
| Device Name: | SPINNING SPIROS, MODEL CH-2000 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2009-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709123332 | K082806 | 000 |
| 10887709121390 | K082806 | 000 |
| 10887709078724 | K082806 | 000 |
| 10840619023314 | K082806 | 000 |
| 10840619023383 | K082806 | 000 |
| 10840619026612 | K082806 | 000 |
| 10840619027565 | K082806 | 000 |
| 10840619033917 | K082806 | 000 |
| 10840619033924 | K082806 | 000 |
| 10840619053632 | K082806 | 000 |
| 10840619065741 | K082806 | 000 |
| 10887709035604 | K082806 | 000 |
| 10887709035611 | K082806 | 000 |
| 10887709071831 | K082806 | 000 |
| 10887709076331 | K082806 | 000 |
| 10887709098678 | K082806 | 000 |
| 10840619034174 | K082806 | 000 |