Edwards Balloon Catheter
FDA 510(k) clearance K153069 · decided 2016-01-07
Clearance details
- K-number
- K153069
- Device name
- Edwards Balloon Catheter
- Applicant
- Edwards Lifesciences
- Decision
- Substantially Equivalent
- Date received
- 2015-10-22
- Decision date
- 2016-01-07
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- OMZ
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDA PTV DILATATON CATHETER (K131002) | C.R. Bard, Inc. | 2013-07-02 |
| BARD PTV DILATATION CATHETER (K122367) | C.R. Bard, Inc. | 2012-11-02 |
| MULLINS-X PTV CATHETER (K102473) | NuMED, Inc. | 2010-12-09 |
| NUMED COEFFICIENT PTV CATHETERS (K014124) | NuMED, Inc. | 2002-01-16 |
Recalls involving this device
No recalls on record reference this clearance.