510(k) K980290 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ITI STENT
| Applicant | Intratherapeutics, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Jul 21, 1998 |
| Received | Jan 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2008 | Ev3, Inc ev3 IntraStent Biliary Stent, Model Number: S10-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001. Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000. Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001. Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002.
ev3 IntraStent DoubleStrut Peripheral Stent, Model Num Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut
Large Diameter Biliary Stent, Model Number: S15-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000.
ev3 IntraStent LD DoubleStrut
Large Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36,
ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002.
ev3 IntraStent LD DoubleStrut La Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-000
ev3 IntraStent LD Mega Large Diameter Peri Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-001.
ev3 IntraStent LD Mega Large Diameter Perip Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-002.
ev3 IntraStent LD Mega Large Diameter Periph Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000.
ev3 IntraStent LD Max Large Diameter Peripher Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001.
ev3 IntraStent LD Max Large Diameter Periphera Terminated |
FGE | None listed |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-002.
ev3 IntraStent LD Max Large Diameter Periphera Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.