510(k) K050814 ยท JCT Prosthesis, Tracheal, Expandable
ATRIUM ICAST COVERED STENT
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, May 6, 2005 |
| Received | Mar 31, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2022 | Atrium Medical Corporation iCast Covered Stent System
Product Code/Part Number:
85400
85401
85402
85403
85404
85405
85406
85407
85408
85409
85410
85411
85412
85413
85414
85415
85416
85417
85418
85419
85420
85424
85440
85441
85 Open, Classified |
JCT | None listed |
| Jul 7, 2017 | Atrium Medical Corporation Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only)
Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/P Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.