FDA 510(k), K101659, SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

FDA 510(k), K101659, SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

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510(K) Number: K101659
Device Name: SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
Manufacturer: VASCULAR SOLUTIONS, INC.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 06/11/2010
Decision Date: 12/16/2010
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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