Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2018-08-07 under approval 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. It is manufactured by Bio Compression Systems, Inc.. The 510(k) number is K180248.

When was VascuEase IC-1200-WH approved by the FDA?

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

What company makes VascuEase IC-1200-WH?

VascuEase IC-1200-WH is manufactured by Bio Compression Systems, Inc..

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

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

Other Devices by Bio Compression Systems, Inc.

K171793Sequential Circulator SC-2004FC-OC 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 K250974Bio Arterial Deluxe (IC-BAP-DX)

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

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.

↑