The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Embol-x Intra-aortic Filter: Extra-small, Small, Medium, Large, Extra-large.
| Device ID | K031946 |
| 510k Number | K031946 |
| Device Name: | EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | EDWARDS LIFESCIENCES, LLC. 1635A SOUTH MAIN STREET Milpitas, CA 94043 |
| Contact | Jean Chang |
| Correspondent | Jean Chang EDWARDS LIFESCIENCES, LLC. 1635A SOUTH MAIN STREET Milpitas, 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 | 2003-06-24 |
| Decision Date | 2003-11-03 |
| Summary: | summary |