EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
FDA 510(k) clearance K022071 · decided 2003-02-14
Clearance details
- K-number
- K022071
- Device name
- EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
- Applicant
- Embol-X, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-26
- Decision date
- 2003-02-14
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, E recall (Z-0091-2014) | Edwards Lifesciences, LLC | 2013-10-31 |