The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Clear Intravacular Arteriotomy Shunt.
| Device ID | K120612 |
| 510k Number | K120612 |
| Device Name: | MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
| Contact | Kelley Breheim |
| Correspondent | Kelley Breheim MEDTRONIC INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-29 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074257464 | K120612 | 000 |
| 00885074257457 | K120612 | 000 |
| 00885074257440 | K120612 | 000 |
| 00885074257433 | K120612 | 000 |
| 00885074257426 | K120612 | 000 |
| 00885074257419 | K120612 | 000 |
| 00885074257402 | K120612 | 000 |
| 00885074257112 | K120612 | 000 |