Submission Details
| 510(k) Number | K180248 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2018 |
| Decision Date | August 07, 2018 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
VascuEase IC-1200-WH
Aug 2018
Decision
190d
Days
Class 2
Risk
About This 510(k) Submission
K180248 is an FDA 510(k) clearance for the VascuEase IC-1200-WH, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on August 7, 2018, 190 days after receiving the submission on January 29, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.
Device Classification
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5800 |
Manufacturer
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