510(k) K142080 ยท LHC Warmer, Irrigation Solution
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
| Applicant | Ecolab, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Aug 28, 2014 |
| Received | Jul 31, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery. Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery. Terminated |
LHC | None listed |
| Sep 18, 2015 | Ecolab Inc Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331
and ORS-2200.
The ORS Fluid Warming and Terminated |
LHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.