The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extracorporeal Subclavian Catheter Kit.
| Device ID | K823752 |
| 510k Number | K823752 |
| Device Name: | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT |
| Classification | Cannula, A-v Shunt |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, 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 | 1982-12-14 |
| Decision Date | 1983-01-14 |