510(k) K182985 ยท DQX Wire, Guide, Catheter
Roadrunner PC Wire Guide, Olcott Torque Device
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 22, 2019 |
| Received | Oct 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (Nimble), Guidewire
Reference Part Number/GPN:
RFSPC-35-145 G09607 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (Nimble Floppy), Guidewire
RFPC-35-145 G07914 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (The Firm LT), Guidewire
Reference Part Number/GPN
RLPC-35-145 G06866 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (The Firm), Guidewire
Reference Part Number/GPN
RPC-35-145 G06979
RPC-35-80 G09534 Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN)RFPC-35-180
ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): RFSPC-35-180
ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN):RLPC-35-180
ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): RPC-35-180
ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.