The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemasite Vascular Access Shunt Hm-1000.
| Device ID | K813237 |
| 510k Number | K813237 |
| Device Name: | HEMASITE VASCULAR ACCESS SHUNT HM-1000 |
| Classification | Cannula, A-v Shunt |
| Applicant | RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-10 |
| Decision Date | 1981-11-30 |