ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire— 510(k) K143587
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K143587 for ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire, Substantially Equivalent on 2015-01-15. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- 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
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code DQX
view allMore clearances from Boston Scientific Corporation
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 K143587
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143587.
Data sourced from openFDA. This site is unofficial and independent of the FDA.