510(k) K991653 ยท FPA Set, Administration, Intravascular
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
| Applicant | Rymed Technologies, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 24, 1999 |
| Received | May 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2016 | Rymed Technologies, LLC InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use
Products are intended for single patient use in intravenous and blood administration sets without the need for n Terminated |
FPA | None listed |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Terminated |
FPA | None listed |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin Terminated |
FPA | None listed |
| Dec 30, 2006 | Rymed Technologies, Inc. RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.