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 |