The following data is part of a premarket notification filed by Cardiogard Medical Ltd with the FDA for Cardiogard Emboli Protection Cannula.
| Device ID | K141465 |
| 510k Number | K141465 |
| Device Name: | CARDIOGARD EMBOLI PROTECTION CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIOGARD MEDICAL LTD 125 CHERRY LANE Armherst, MA 01002 |
| Contact | Sheila H Heyer |
| Correspondent | Sheila H Heyer CARDIOGARD MEDICAL LTD 125 CHERRY LANE Armherst, MA 01002 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-03 |
| Decision Date | 2015-01-09 |
| Summary: | summary |