EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
FDA 510(k) clearance K132175 · decided 2013-09-13
Clearance details
- K-number
- K132175
- Device name
- EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-07-15
- Decision date
- 2013-09-13
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edwards Lifesciences
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), recall (Z-1705-2019) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 F recall (Z-1758-2015) | Edwards Lifesciences, LLC | 2015-06-11 |