510(k) K012403 ยท JOW Sleeve, Limb, Compressible
VANGUARD REPROCESSED COMPRESSION GARMENT
| Applicant | Vanguard Medical Concepts, Inc., Lakeland FL, US |
| Decision | Substantially Equivalent, Oct 17, 2001 |
| Received | Jul 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2017 | Stryker Sustainability Solutions 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector.
Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and Terminated |
JOW | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. Terminated |
JOW | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.