510(k) K123987 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
| Applicant | Innovative Medical Technologies, Inc., Leawood KS, US |
| Decision | Substantially Equivalent, Aug 27, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2017 | Guangzhou Improve Medical Instruments Co., Ltd. Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO Open, Classified |
FMI | None listed |
| Sep 22, 2017 | Guangzhou Improve Medical Instruments Co., Ltd. Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer Open, Classified |
FMI | None listed |
| Oct 19, 2016 | Guangzhou Improve Medical Instruments Co., Ltd. Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO
Product Usage:
The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adap Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.