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FDA 510(k), K151244, Pre-Formed Guidewire
FDA 510(k), K151244, Pre-Formed Guidewire
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510(K) Number: K151244
Device Name: Pre-Formed Guidewire
Manufacturer: Mathew Pexa
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 05/11/2015
Decision Date: 06/11/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Pre-Formed Guidewire
Manufacturer: Mathew Pexa
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 05/11/2015
Decision Date: 06/11/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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