The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for Modification To Embol-x Intra-aortic Filter: X-small, Small, Medium, Large, X-large With Heparin Coated Mesh.
| Device ID | K062429 |
| 510k Number | K062429 |
| Device Name: | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Karen Jones |
| Correspondent | Karen Jones EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103166378 | K062429 | 000 |
| 00690103166361 | K062429 | 000 |
| 00690103166354 | K062429 | 000 |
| 00690103166347 | K062429 | 000 |
| 00690103166330 | K062429 | 000 |