510(k) K171764 ยท DQX Wire, Guide, Catheter
Fixed Core Wire Guides
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 9, 2018 |
| Received | Jun 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Cook Incorporated Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFBP-35-180 (GPN G09782)
TSFBP-35-145 (GPN G09735) Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFB-35-80 (GPN G01315)
TSFB-35-145 (GPN G00691)
TSFB-35-200 (GPN G01095) Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Coons Interventional Wire Guide, Guidewire;
Reference Part Number/GPN:
THSF-35-145-COONS G02356
THSF-38-145-COONS G02324
THSF-35-180-COONS G02621
THSF-35-80-COONS G12268 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-25-180-3 G02165
TSCF-25-80-3 G00476 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide (Safe-T-J Curved), Guidewire
Reference Part Number/GPN:
TSCF-25-180-3 G01602
TSCF-35-180-3 G00902
TSCF-21-260-3 G00455
THSCF-25-260-3 G02384
TSCF-25-145-3 G00466
THSCF-35-80-3 G0 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide (Straight), Guidewire
Reference Part Number/GPN:
C-SF-18-30 G02261
C-SF-25-40 G01937
TSF-18-260 G00590
C-SF-25-50 G01938
TSF-35-180 G00652
C-SF-18-40 G02255
TSF-25-145 G00617
TSF Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire
Reference Part Number/GPN:
TSFNA-35-145 G00701
TSCFNA-35-145-3 G00561 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Rosen Curved Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-35-220-1.5-ROSEN G01623
THSCF-35-80-1.5-ROSEN G01774
THSCF-35-180-1.5-ROSEN G01264
THSCF-35-145-1.5-ROSEN G01261 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Lunderquist -Ring Torque Wire Guide, Guidewire
Reference Part Number/GPN
THSF-35-125-THG G27031
THSF-35-145-THG G27033 Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.