THE AMPLATZ THROMBECTOMY DEVICE— 510(k) K954205
Substantially EquivalentMicrovena Corp.
FDA 510(k) clearance K954205 for THE AMPLATZ THROMBECTOMY DEVICE, Substantially Equivalent on 1996-08-13. Applicant: Microvena Corp.. Device class: 2.
Clearance details
- Applicant
- Microvena Corp.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- White Bear Lake, MN, US
Recent devices under product code MCW
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 MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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.