510(k) K110009 ยท DQX Wire, Guide, Catheter
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Feb 2, 2011 |
| Received | Jan 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPW-35-150
ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedu Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-18-150
ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional proced Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-18-80
ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional proced Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-35-150
ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-35-80
ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWAS-35-150
ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWAS-35-80
ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWS-35-150
ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWS-35-80
ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | None listed |
| Aug 25, 2016 | Cook Inc. Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-3 Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.