Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter— 510(k) K163314
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K163314 for Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter, Substantially Equivalent on 2017-03-23. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code DQY
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K163314
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 K163314.
Data sourced from openFDA. This site is unofficial and independent of the FDA.