FDA 510(k), K173841, AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
FDA 510(k), K173841, AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
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$149.00 USD
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$149.00 USD
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510(K) Number: K173841
Device Name: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Manufacturer: Angelica Beckmann
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 12/18/2017
Date Received: 03/18/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Manufacturer: Angelica Beckmann
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 12/18/2017
Date Received: 03/18/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology