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FDA 510(k)

Bio Arterial Deluxe (IC-BAP-DX)

K-Number: K250974 · 2025-12-12

ApplicantBio Compression Systems, Inc.
Decision Date2025-12-12
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bio Arterial Deluxe (IC-BAP-DX) is a medical device manufactured by Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2025-12-12 under approval number K250974. 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 Bio Arterial Deluxe (IC-BAP-DX)?

Bio Arterial Deluxe (IC-BAP-DX) is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Bio Compression Systems, Inc.. The 510(k) number is K250974.

When was Bio Arterial Deluxe (IC-BAP-DX) approved by the FDA?

Bio Arterial Deluxe (IC-BAP-DX) received FDA 510(k) clearance on 2025-12-12, under approval number K250974.

What company makes Bio Arterial Deluxe (IC-BAP-DX)?

Bio Arterial Deluxe (IC-BAP-DX) is manufactured by Bio Compression Systems, Inc..

What is the FDA product code for Bio Arterial Deluxe (IC-BAP-DX)?

The FDA product code for Bio Arterial Deluxe (IC-BAP-DX) is JOW.

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 K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

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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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