The following data is part of a premarket notification filed by Bellco Srl with the FDA for Clearum Hs Family, Clearum Hs Models: Hs 13, Hs 15, Hs 17, Hs 20, Hs 22.
| Device ID | K193542 |
| 510k Number | K193542 |
| Device Name: | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Bellco Srl Via Camurana 1 Mirandola, IT 41037 |
| Contact | Rekha Roveri |
| Correspondent | Michele Gust Medtronic, Inc. 710 Medtronic Parkway (LT140) Minneapolis, MN 55432 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 68051736004170 | K193542 | 000 |
| 68051736004163 | K193542 | 000 |
| 68051736004156 | K193542 | 000 |
| 68051736004149 | K193542 | 000 |
| 68051736004132 | K193542 | 000 |