The following data is part of a premarket notification filed by Embol-x, Inc. with the FDA for Embol-x Aortic Filters,etra-small,small,medium,large,extra Large,models Cf26000.cf29000,cf32000,cf35000,cf4000.
| Device ID | K022071 |
| 510k Number | K022071 |
| Device Name: | EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | EMBOL-X, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Ed Lee |
| Correspondent | Ed Lee EMBOL-X, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-26 |
| Decision Date | 2003-02-14 |
| Summary: | summary |