FDA 510(k), K192525, 087 Balloon Guide Catheter System
FDA 510(k), K192525, 087 Balloon Guide Catheter System
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$149.00 USD
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510(K) Number: K192525
Device Name: 087 Balloon Guide Catheter System
Manufacturer: Ken Peartree
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: 09/13/2019
Date Received: 10/31/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: 087 Balloon Guide Catheter System
Manufacturer: Ken Peartree
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: 09/13/2019
Date Received: 10/31/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology