The following data is part of a premarket notification filed by Cardiogard Medical Ltd with the FDA for Cardiogard Emboli Protection Cannula.
| Device ID | K182302 |
| 510k Number | K182302 |
| Device Name: | CardioGard Emboli Protection Cannula |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CardioGard Medical Ltd 6 Yoni Netanyahu Street Or-yehuda, IL 6037604 |
| Contact | Orit Ronan |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions, LLC 125 Cherry Lane Amherst, 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 | 2018-08-24 |
| Decision Date | 2019-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016069013 | K182302 | 000 |