The following data is part of a premarket notification filed by Sorensen Research with the FDA for Ssc8 Sorenson Subclavian Catheter.
| Device ID | K801478 |
| 510k Number | K801478 |
| Device Name: | SSC8 SORENSON SUBCLAVIAN CATHETER |
| Classification | Cannula, A-v Shunt |
| Applicant | SORENSEN RESEARCH 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 | 1980-06-24 |
| Decision Date | 1980-08-27 |