The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Careline Airless Hemodialysis Blood Tubing Sets.
| Device ID | K172238 |
| 510k Number | K172238 |
| Device Name: | CAREline Airless Hemodialysis Blood Tubing Sets |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 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 | 2017-07-26 |
| Decision Date | 2017-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861100415 | K172238 | 000 |
| 10840861100405 | K172238 | 000 |