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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: K213533 · 2022-02-16

ApplicantBio Compression Systems, Inc.
Decision Date2022-02-16
Product CodeIRP
Advisory CommitteePM
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 2022-02-16 under approval number K213533. The device is classified under product code IRP. It was reviewed by the PM 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 2022-02-16. It is manufactured by Bio Compression Systems, Inc.. The 510(k) number is K213533.

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 2022-02-16, under approval number K213533.

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 IRP.

Other Devices by Bio Compression Systems, Inc.

K171793Sequential Circulator SC-2004FC-OC K180248VascuEase IC-1200-WH K210417Sequential 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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