FDA 510(k)

PSA Cable

K-Number: K170815 · 2017-07-06

Decision Date2017-07-06

Product CodeDTC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PSA Cable is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K170815. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSA Cable?

PSA Cable is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Boston Scientific Corporation. The 510(k) number is K170815.

When did PSA Cable receive FDA 510(k) clearance?

PSA Cable received FDA 510(k) clearance on 2017-07-06, under 510(k) number K170815.

Who is the listed applicant for PSA Cable?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSA Cable?

The FDA product code for PSA Cable is DTC.

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Official Source

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