The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Catheters, Arterial Embolectomy.
| Device ID | K780244 |
| 510k Number | K780244 |
| Device Name: | CATHETERS, ARTERIAL EMBOLECTOMY |
| Classification | Catheter, Embolectomy |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-13 |
| Decision Date | 1978-04-13 |