Approach CTO Microwire Guide— 510(k) K171897
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K171897 for Approach CTO Microwire Guide, Substantially Equivalent on 2017-08-21. 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 K171897
K-number listed on FDA's recall record- Z-1775-2026 — COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
- Z-0499-2025 — Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Z-0346-2025 — Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171897.
Data sourced from openFDA. This site is unofficial and independent of the FDA.