510(k) K142889 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Celerity PICC Tip Confirmation System
| Applicant | AngioDynamics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jan 27, 2015 |
| Received | Oct 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2017 | Angiodynamics Inc. (Navilyst Medical Inc.) Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Terminated |
LJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.