Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter.

Pre-market Notification Details

• Device ID: K211375
• 510k Number: K211375
• Device Name: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 -5798
• Contact: Donall Hosna
• Correspondent: Donall Hosna; Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 -5798
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-04
• Decision Date: 2021-09-10