510(k) K132841 ยท FPA Set, Administration, Intravascular
ZYNO MEDICAL ADMINISTRATION SET
| Applicant | Zyno Medical, LLC, Natick MA, US |
| Decision | Substantially Equivalent, Jan 23, 2014 |
| Received | Sep 10, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132841
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2019 | Zyno Medical LLC Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed
Product Code:B2-70072 Terminated |
FPA | None listed |
| May 29, 2019 | Zyno Medical LLC Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed
Product Code: B2-70072-F Terminated |
FPA | None listed |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: A2-80071-DF
Product Code: A2-80071-DF-120 (Expanded recall)
Product Usage:
Zyno Med Terminated |
FPA | None listed |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: A2-80072-F
Product Usage:
Zyno Medical Administration Set is a device used to admini Terminated |
FPA | None listed |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set, Sterile. RX
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70071-DF
Product Code: B2-70071-DF-120 (expanded recall)
Product Usage:
Zyno Med Terminated |
FPA | None listed |
| Sep 27, 2016 | Zyno Medical LLC Zyno Medical Administration Set Sterile. Rx
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70072-F
Product Usage:
Zyno Medical Administration Set is a device used to adminis Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.