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FDA 510(k)

CIRCUL8 Connect DVT Prevention Device

K-Number: K220761 · 2022-06-03

ApplicantOrtho8, Inc.
Decision Date2022-06-03
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCUL8 Connect DVT Prevention Device is the device name listed in this FDA 510(k) record. The listed applicant is Ortho8, Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220761. 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 CIRCUL8 Connect DVT Prevention Device?

CIRCUL8 Connect DVT Prevention Device is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Ortho8, Inc.. The 510(k) number is K220761.

When did CIRCUL8 Connect DVT Prevention Device receive FDA 510(k) clearance?

CIRCUL8 Connect DVT Prevention Device received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220761.

Who is the listed applicant for CIRCUL8 Connect DVT Prevention Device?

The FDA 510(k) record lists Ortho8, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRCUL8 Connect DVT Prevention Device?

The FDA product code for CIRCUL8 Connect DVT Prevention Device is JOW.

Other records listing Ortho8, Inc. 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.

K212731Circul8 ProK211235CIRCUL8 Luxe DVT Prevention Device

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.

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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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