510(k) K091077 ยท DTK Filter, Intravascular, Cardiovascular
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
| Applicant | Cordis Corp., A Johnson & Johnson Co., Bridgewater NJ, US |
| Decision | Substantially Equivalent, Feb 4, 2010 |
| Received | Apr 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2013 | Cordis Corporation Cordis OPTEASE Vena Cava Filter
Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromb Terminated |
DTK | None listed |
| Aug 7, 2013 | Cordis Corporation Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Terminated |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.