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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 a medical device manufactured by Ortho8, Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval 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. It is manufactured by Ortho8, Inc.. The 510(k) number is K220761.

When was CIRCUL8 Connect DVT Prevention Device approved by the FDA?

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

What company makes CIRCUL8 Connect DVT Prevention Device?

CIRCUL8 Connect DVT Prevention Device is manufactured by Ortho8, Inc..

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

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

Related Clinical Trials

NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT05069558 Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion ACTIVE_NOT_RECRUITING NCT07600463 UVC in Prevention of Surgical Wound Infection NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT05116176 TRAjectories and CLinical ExpeRiences of ICD Therapy Study ENROLLING_BY_INVITATION NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40833550 Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions. Drug safety (2026) PMID: 39556835 Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals of internal medicine (2024)

Other Devices by Ortho8, Inc.

K212731Circul8 Pro K211235CIRCUL8 Luxe DVT Prevention Device

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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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