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FDA 510(k)

VascuEase IC-1200-WH

K-Number: K180248 · 2018-08-07

ApplicantBio Compression Systems, Inc.
Decision Date2018-08-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VascuEase IC-1200-WH is the device name listed in this FDA 510(k) record. The listed applicant is Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K180248. 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 VascuEase IC-1200-WH?

VascuEase IC-1200-WH is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K180248.

When did VascuEase IC-1200-WH receive FDA 510(k) clearance?

VascuEase IC-1200-WH received FDA 510(k) clearance on 2018-08-07, under 510(k) number K180248.

Who is the listed applicant for VascuEase IC-1200-WH?

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

What is the FDA product code for VascuEase IC-1200-WH?

The FDA product code for VascuEase IC-1200-WH is JOW.

Other records listing Bio Compression Systems, 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.

K250974Bio Arterial Deluxe (IC-BAP-DX)K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK171793Sequential Circulator SC-2004FC-OC

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

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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