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FDA 510(k), K133023, JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
FDA 510(k), K133023, JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
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510(K) Number: K133023
Device Name: JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
Manufacturer: MEDRAD, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 09/26/2013
Decision Date: 08/27/2014
Regulation Medical Specialty: Cardiovascular
Device Name: JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
Manufacturer: MEDRAD, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 09/26/2013
Decision Date: 08/27/2014
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks
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