Double Flexible Tip Wire Guides— 510(k) K171912
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K171912 for Double Flexible Tip Wire Guides, Substantially Equivalent on 2018-03-19. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
Recent devices under product code DQX
view allMore clearances from Cook Incorporated
view allAdverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K171912
K-number listed on FDA's recall record- Z-1831-2022 — Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
- Z-1835-2022 — Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171912.
Data sourced from openFDA. This site is unofficial and independent of the FDA.