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FDA 510(k), K221351, Mechanical Guidewire
FDA 510(k), K221351, Mechanical Guidewire
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510(K) Number: K221351
Device Name: Mechanical Guidewire
Manufacturer: May Tsai
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 05/10/2022
Decision Date: 12/19/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Mechanical Guidewire
Manufacturer: May Tsai
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 05/10/2022
Decision Date: 12/19/2022
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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