510(k) K911732 ยท IZI System, X-Ray, Angiographic
ADVANCE DISPOSABLE CONTROL SYRINGE
| Applicant | Advance Medical Designs, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Sep 16, 1991 |
| Received | Apr 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2005 | Argon Medical Devices, Inc Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:
Product Label
''***Argon Medical Device***10cc Control Syringe F Terminated |
IZI | None listed |
| Aug 3, 2005 | Argon Medical Devices, Inc Labeling is as follows:
Product Labeling:
''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy Terminated |
IZI | None listed |
| Aug 3, 2005 | Argon Medical Devices, Inc Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:
Product Label
''***Argon Medical Device***REORDER NO./REF 193205 Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.