The following data is part of a premarket notification filed by Cardio Med Supplies, Inc. with the FDA for Tubing For Cardiopulmonary Bypass.
| Device ID | K833112 |
| 510k Number | K833112 |
| Device Name: | TUBING FOR CARDIOPULMONARY BYPASS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIO MED SUPPLIES, 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 | 1983-08-16 |
| Decision Date | 1983-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 36641670000836 | K833112 | 000 |
| 16641670004380 | K833112 | 000 |
| 16641670004366 | K833112 | 000 |
| 16641670004342 | K833112 | 000 |
| 16641670004328 | K833112 | 000 |
| 16641670004304 | K833112 | 000 |
| 16641670004281 | K833112 | 000 |
| 16641670004267 | K833112 | 000 |
| 16641670004243 | K833112 | 000 |
| 16641670004229 | K833112 | 000 |
| 16641670004205 | K833112 | 000 |
| 16641670004182 | K833112 | 000 |
| 16641670004168 | K833112 | 000 |
| 16641670001341 | K833112 | 000 |
| 16641670001327 | K833112 | 000 |
| 16641670004403 | K833112 | 000 |
| 16641670004427 | K833112 | 000 |
| 16641670004441 | K833112 | 000 |
| 16641670004724 | K833112 | 000 |
| 16641670004700 | K833112 | 000 |
| 16641670004687 | K833112 | 000 |
| 16641670004663 | K833112 | 000 |
| 16641670004649 | K833112 | 000 |
| 16641670004625 | K833112 | 000 |
| 16641670004601 | K833112 | 000 |
| 16641670004588 | K833112 | 000 |
| 16641670004564 | K833112 | 000 |
| 16641670004540 | K833112 | 000 |
| 16641670004526 | K833112 | 000 |
| 16641670004502 | K833112 | 000 |
| 16641670004489 | K833112 | 000 |
| 16641670004465 | K833112 | 000 |
| 16641670001303 | K833112 | 000 |