NovaGold High Performance Guidewire— 510(k) K150225
Substantially EquivalentNeometrics, Inc.
FDA 510(k) clearance K150225 for NovaGold High Performance Guidewire, Substantially Equivalent on 2015-03-16. Applicant: Neometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Neometrics, Inc.
- Product code
- Code OCY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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- K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE
More clearances from Neometrics, Inc.
view allAdverse events under product code OCY
product code OCY- Injury
- 186
- Malfunction
- 578
- Total
- 764
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.