FDA 510(k)

Fixed Patient Leads ECG Cable (Model 3153)

K-Number: K172591 · 2017-11-03

Decision Date2017-11-03

Product CodeDSA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fixed Patient Leads ECG Cable (Model 3153) 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 2017-11-03 under 510(k) number K172591. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fixed Patient Leads ECG Cable (Model 3153)?

Fixed Patient Leads ECG Cable (Model 3153) is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Boston Scientific Corporation. The 510(k) number is K172591.

When did Fixed Patient Leads ECG Cable (Model 3153) receive FDA 510(k) clearance?

Fixed Patient Leads ECG Cable (Model 3153) received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172591.

Who is the listed applicant for Fixed Patient Leads ECG Cable (Model 3153)?

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 Fixed Patient Leads ECG Cable (Model 3153)?

The FDA product code for Fixed Patient Leads ECG Cable (Model 3153) is DSA.

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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.