The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Select 3d Arterial Cannula.
| Device ID | K043179 |
| 510k Number | K043179 |
| Device Name: | SELECT 3D ARTERIAL CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Ronald W Bennett |
| Correspondent | Ronald W Bennett MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-11-17 |
| Decision Date | 2005-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169696273 | K043179 | 000 |
| 20613994878926 | K043179 | 000 |
| 20613994878933 | K043179 | 000 |
| 20613994878940 | K043179 | 000 |
| 20613994878957 | K043179 | 000 |
| 20613994878964 | K043179 | 000 |
| 20613994878971 | K043179 | 000 |
| 20643169486267 | K043179 | 000 |
| 20643169486274 | K043179 | 000 |
| 20643169486281 | K043179 | 000 |
| 00643169158924 | K043179 | 000 |
| 00643169158948 | K043179 | 000 |
| 00643169158955 | K043179 | 000 |
| 00763000946869 | K043179 | 000 |