The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Intersept* Venous Reservoir Bag & Holder.
| Device ID | K803059 |
| 510k Number | K803059 |
| Device Name: | INTERSEPT* VENOUS RESERVOIR BAG & HOLDER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-03 |
| Decision Date | 1980-12-22 |