FDA 510(k)

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable

K-Number: K230503 · 2023-04-25

Decision Date2023-04-25

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2023-04-25 under approval number K230503. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable?

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Boston Scientific. The 510(k) number is K230503.

When was Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable approved by the FDA?

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable received FDA 510(k) clearance on 2023-04-25, under approval number K230503.

What company makes Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable?

Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable is manufactured by Boston Scientific.

What is the FDA product code for Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable?

The FDA product code for Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable is DRF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.