SOLOSTICK (AMPLATZ DILATOR NEEDLE)— 510(k) K896096
Substantially EquivalentMicrovena Corp.
FDA 510(k) clearance K896096 for SOLOSTICK (AMPLATZ DILATOR NEEDLE), Substantially Equivalent on 1990-04-10. Applicant: Microvena Corp.. Device class: 2.
Clearance details
- Applicant
- Microvena Corp.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Findley, MN, US
Recent devices under product code DRE
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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 DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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.