The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Cardiac Insulation Pad.
| Device ID | K781990 |
| 510k Number | K781990 |
| Device Name: | CARDIAC INSULATION PAD |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-27 |
| Decision Date | 1978-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622131896 | K781990 | 000 |
| 10803622131889 | K781990 | 000 |