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FDA 510(k)

Capiflo 5001

K-Number: K222158 · 2023-01-20

ApplicantK&L Distributing, Inc.
Decision Date2023-01-20
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Capiflo 5001 is the device name listed in this FDA 510(k) record. The listed applicant is K&L Distributing, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222158. 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 Capiflo 5001?

Capiflo 5001 is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is K&L Distributing, Inc.. The 510(k) number is K222158.

When did Capiflo 5001 receive FDA 510(k) clearance?

Capiflo 5001 received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222158.

Who is the listed applicant for Capiflo 5001?

The FDA 510(k) record lists K&L Distributing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capiflo 5001?

The FDA product code for Capiflo 5001 is JOW.

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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.

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