FDA 510(k), K123279, MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
FDA 510(k), K123279, MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
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510(K) Number: K123279
Device Name: MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
Manufacturer: Abbott Vascular
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 10/22/2012
Decision Date: 01/30/2013
Regulation Medical Specialty: Cardiovascular
Device Name: MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
Manufacturer: Abbott Vascular
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 10/22/2012
Decision Date: 01/30/2013
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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