The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad High Pressure Conecting Tube.
| Device ID | K810924 |
| 510k Number | K810924 |
| Device Name: | MEDRAD HIGH PRESSURE CONECTING TUBE |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | MEDRAD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-06 |
| Decision Date | 1981-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40616258008538 | K810924 | 000 |
| 40616258008521 | K810924 | 000 |
| 40616258008514 | K810924 | 000 |
| 40616258008507 | K810924 | 000 |
| 60616258021531 | K810924 | 000 |