510(k) K190843 ยท MOF Guide, Wire, Catheter, Neurovasculature
Synchro2 Support Guidewire
| Applicant | Stryker, Fremont CA, US |
| Decision | Substantially Equivalent, May 1, 2019 |
| Received | Apr 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neuro Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, inc Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurov Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, incl Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including ne Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neur Terminated |
DQX | None listed |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.