The following data is part of a premarket notification filed by Xcardia Innovation Ltd. with the FDA for Xtractor Device.
| Device ID | K211679 |
| 510k Number | K211679 |
| Device Name: | Xtractor Device |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Xcardia Innovation Ltd. 1 Hamada Street Rehovot, IL 7670301 |
| Contact | Benny Rousso |
| Correspondent | Orly Maor Orly Maor 25 Sirkin Street Kfar Saba, IL 4442156 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2022-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290019371007 | K211679 | 000 |
| 07290019371014 | K211679 | 000 |