The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes).
| Device ID | K022272 |
| 510k Number | K022272 |
| Device Name: | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON ST. SW Grand Rapids, MI 49504 -6393 |
| Contact | Roger Brink |
| Correspondent | Roger Brink MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON ST. SW Grand Rapids, MI 49504 -6393 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2003-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169083787 | K022272 | 000 |
| 20613994879343 | K022272 | 000 |
| 20613994879350 | K022272 | 000 |
| 20613994879367 | K022272 | 000 |
| 20613994879374 | K022272 | 000 |
| 20613994879381 | K022272 | 000 |
| 20613994879398 | K022272 | 000 |
| 20613994879404 | K022272 | 000 |
| 20613994879411 | K022272 | 000 |
| 20613994879428 | K022272 | 000 |
| 20613994879435 | K022272 | 000 |
| 20613994879442 | K022272 | 000 |
| 20613994879459 | K022272 | 000 |
| 20613994879466 | K022272 | 000 |
| 20613994879473 | K022272 | 000 |
| 20613994879336 | K022272 | 000 |