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FDA 510(k)

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

K-Number: K210417 · 2021-05-14

ApplicantBio Compression Systems, Inc.
Decision Date2021-05-14
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is a medical device manufactured by Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2021-05-14 under approval number K210417. 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 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Bio Compression Systems, Inc.. The 510(k) number is K210417.

When was Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL approved by the FDA?

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL received FDA 510(k) clearance on 2021-05-14, under approval number K210417.

What company makes Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is manufactured by Bio Compression Systems, Inc..

What is the FDA product code for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

The FDA product code for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is JOW.

Other Devices by Bio Compression Systems, Inc.

K171793Sequential Circulator SC-2004FC-OC K180248VascuEase IC-1200-WH K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL K250974Bio Arterial Deluxe (IC-BAP-DX)

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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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