The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Hospira Cath Lab Convenience Kits.
| Device ID | K052865 |
| 510k Number | K052865 |
| Device Name: | HOSPIRA CATH LAB CONVENIENCE KITS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ICU MEDICAL, INC. 275 North Field Drive Lake Forest, IL 60045 |
| Contact | Tom Kozma |
| Correspondent | Tom Kozma ICU MEDICAL, INC. 275 North Field Drive Lake Forest, IL 60045 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942970384 | K052865 | 000 |
| 10888277779983 | K052865 | 000 |
| 10887709061207 | K052865 | 000 |
| 10887709053691 | K052865 | 000 |
| 10887709051277 | K052865 | 000 |
| 10887709043920 | K052865 | 000 |
| 10840619060975 | K052865 | 000 |
| 10840619045439 | K052865 | 000 |
| 10840619040915 | K052865 | 000 |
| 10888277983700 | K052865 | 000 |
| 10888277779990 | K052865 | 000 |
| 10888277780002 | K052865 | 000 |
| 10888277780019 | K052865 | 000 |
| 10889942376193 | K052865 | 000 |
| 10889942321476 | K052865 | 000 |
| 10889942312726 | K052865 | 000 |
| 10889942220441 | K052865 | 000 |
| 10889942121083 | K052865 | 000 |
| 10889942120666 | K052865 | 000 |
| 10887709001869 | K052865 | 000 |
| 10193489807950 | K052865 | 000 |
| 10193489620283 | K052865 | 000 |
| 40889942781875 | K052865 | 000 |