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FDA 510(k)

Fixed Patient Leads ECG Cable (Model 3153)

K-Number: K172591 · 2017-11-03

ApplicantBoston Scientific Corporation
Decision Date2017-11-03
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fixed Patient Leads ECG Cable (Model 3153) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-11-03 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K172591.

When was Fixed Patient Leads ECG Cable (Model 3153) approved by the FDA?

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

What company makes Fixed Patient Leads ECG Cable (Model 3153)?

Fixed Patient Leads ECG Cable (Model 3153) is manufactured by Boston Scientific Corporation.

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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Related Devices (Code: DSA)

K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. K152947Disposable Temporary Pacing CableTiger Medical Products K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. K170536ECG Disposable Lead WireAPK Technology Co., Ltd. K162432Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc.

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.

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