510(k) K090012 ยท FPA Set, Administration, Intravascular
DISPOSABLE INFUSION SET
| Applicant | Shan Dong Wei Gao Group Medical Polymer Products, Shan Nan Er Rd., Shanghai, CN |
| Decision | Substantially Equivalent, Jun 11, 2009 |
| Received | Jan 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2015 | US Infusion Inc dba Trucare Biomedix-USA Medstream 81" (206 cm) 20 drop Universal Administration Sets.
Disposable IV infusion set with 3 year expiration date. Terminated |
FPA | None listed |
| Aug 9, 2012 | Medical Specialties Distributors, Inc. Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile
Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China
Product Numb Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.