510(k) K121398 ยท DQX Wire, Guide, Catheter
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
| Applicant | Guidepath Medical, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | May 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 150 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 150 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 180 CM Length;
Ma Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 260 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: ND Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;
0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Inc., Fremont, CA.
The HydroFinity Hydrophilic gu Terminated |
DQX | None listed |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.