The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Carpentier Bi-caval Femoral Cannula.
| Device ID | K140192 |
| 510k Number | K140192 |
| Device Name: | CARPENTIER BI-CAVAL FEMORAL CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
| Contact | Jacqueline A Hauge |
| Correspondent | Jacqueline A Hauge MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169697614 | K140192 | 000 |
| 00643169697607 | K140192 | 000 |
| 00643169697591 | K140192 | 000 |
| 00643169697584 | K140192 | 000 |
| 20643169490134 | K140192 | 000 |
| 20643169490127 | K140192 | 000 |
| 20643169490110 | K140192 | 000 |
| 20643169490103 | K140192 | 000 |