CRUX SNARE FILTER RETRIEVAL SET— 510(k) K133681
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K133681 for CRUX SNARE FILTER RETRIEVAL SET, Substantially Equivalent on 2014-01-30. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code MMX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Recent devices under product code MMX
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- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K190626 — SyncVision System
Adverse events under product code MMX
product code MMX- Death
- 3
- Total
- 3
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.