MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
FDA 510(k) clearance K110617 · decided 2011-06-02
Clearance details
- K-number
- K110617
- Device name
- MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
- Applicant
- Abbott Vascular
- Decision
- Substantially Equivalent
- Date received
- 2011-03-03
- Decision date
- 2011-06-02
- Days to decision
- 91 days
- Clearance type
- Traditional
- 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.