The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for Crit-line Iv System.
| Device ID | K141997 |
| 510k Number | K141997 |
| Device Name: | CRIT-LINE IV SYSTEM |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | FRESENIUS MEDICAL CARE 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE 920 Winter Street Waltham, MA 02451 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2015-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101122 | K141997 | 000 |