PressureWire X Guidewire
FDA 510(k) clearance K161171 · decided 2016-08-15
Clearance details
- K-number
- K161171
- Device name
- PressureWire X Guidewire
- Applicant
- St. Jude Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-26
- Decision date
- 2016-08-15
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094) | St. Jude Medical, Inc. | 2016-02-12 |
| SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093) | St. Jude Medical, Inc. | 2015-08-27 |
| SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092) | St. Jude Medical, Inc. | 2015-02-25 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089) | St. Jude Medical, Inc. | 2014-09-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088) | St. Jude Medical, Inc. | 2014-05-29 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081) | St. Jude Medical, Inc. | 2014-04-10 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085) | St. Jude Medical, Inc. | 2014-03-20 |
| SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087) | St. Jude Medical, Inc. | 2014-02-26 |