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FDA 510(k), K100462, JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
FDA 510(k), K100462, JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
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510(K) Number: K100462
Device Name: JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
Manufacturer: PATHWAY MEDICAL TECHNOLOGIES, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/18/2010
Decision Date: 05/19/2010
Regulation Medical Specialty: Cardiovascular
Device Name: JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
Manufacturer: PATHWAY MEDICAL TECHNOLOGIES, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/18/2010
Decision Date: 05/19/2010
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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