THE NINER NITINOL GUIDEWIRE— 510(k) K952860
Substantially EquivalentMicrovena Corp.
FDA 510(k) clearance K952860 for THE NINER NITINOL GUIDEWIRE, Substantially Equivalent on 1995-12-13. Applicant: Microvena Corp.. Device class: 2.
Clearance details
- Applicant
- Microvena Corp.
- 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
- White Bear Lake, MN, US
Recent devices under product code DQX
view allMore clearances from Microvena Corp.
view all- K991898 — ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
- K991194 — MODIFICATION TO ULTRA-SELECT GUIDEWIRE
- K982657 — AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- K970668 — THE AMPLANTZ GOOSE NECK MICROSNARE
- K972511 — AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.