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FDA 510(k)

Reprocessed Kendall SCD Express Foot Cuff

K-Number: K163055 · 2016-12-23

ApplicantCovidien
Decision Date2016-12-23
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Kendall SCD Express Foot Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K163055. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Kendall SCD Express Foot Cuff?

Reprocessed Kendall SCD Express Foot Cuff is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Covidien. The 510(k) number is K163055.

When did Reprocessed Kendall SCD Express Foot Cuff receive FDA 510(k) clearance?

Reprocessed Kendall SCD Express Foot Cuff received FDA 510(k) clearance on 2016-12-23, under 510(k) number K163055.

Who is the listed applicant for Reprocessed Kendall SCD Express Foot Cuff?

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

What is the FDA product code for Reprocessed Kendall SCD Express Foot Cuff?

The FDA product code for Reprocessed Kendall SCD Express Foot Cuff is JOW.

Other records listing Covidien as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 119 devices →

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.