NC TREK RX CORONARY DILATATION CATHETER
FDA 510(k) clearance K110134 · decided 2011-02-11
Clearance details
- K-number
- K110134
- Device name
- NC TREK RX CORONARY DILATATION CATHETER
- Applicant
- Abbott Vascular-Cardiac Therapies
- Decision
- Substantially Equivalent
- Date received
- 2011-01-18
- Decision date
- 2011-02-11
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Omnilink Elite Vascular Balloon-Expandable Stent System (P110043/S014) | Abbott Vascular-Cardiac Therapies | 2024-09-20 |
| Omnilink Elite Vascular Balloon-Exoandable Stent System (P110043/S013) | Abbott Vascular-Cardiac Therapies | 2022-09-07 |
| Omnilink Elite OTW Stent System (P110043/S012) | Abbott Vascular-Cardiac Therapies | 2020-09-11 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S011) | Abbott Vascular-Cardiac Therapies | 2016-09-14 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S010) | Abbott Vascular-Cardiac Therapies | 2016-05-27 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S008) | Abbott Vascular-Cardiac Therapies | 2014-10-09 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S009) | Abbott Vascular-Cardiac Therapies | 2014-09-30 |
| OMNILINK ELITE VASCULAR BALLON-EXPANDABLE STENT SYSTEM (P110043/S007) | Abbott Vascular-Cardiac Therapies | 2014-09-05 |