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FDA 510(k), K181001, Medtronic Confida Brecker Guidewire
FDA 510(k), K181001, Medtronic Confida Brecker Guidewire
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510(K) Number: K181001
Device Name: Medtronic Confida Brecker Guidewire
Manufacturer: Gerardine Drummond
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 04/16/2018
Decision Date: 05/03/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Medtronic Confida Brecker Guidewire
Manufacturer: Gerardine Drummond
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 04/16/2018
Decision Date: 05/03/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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