510(k) K925020 ยท JOH Tube Tracheostomy And Tube Cuff
TRACHEOSTOMY CARE KIT (STERILE)
| Applicant | Customed, Inc., Fajardo PR, US |
| Decision | Unknown, Jul 7, 1993 |
| Received | Sep 24, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, Terminated |
NXA | None listed |
| Sep 3, 2015 | Customed, Inc TRACHEOTOMY CARE KIT CUSTOMED 50/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
NXA | None listed |
| Mar 21, 2012 | Customed, Inc Tracheotomy care kit, catalog# 900-110 Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.