EQUALIZER OCCLUSION BALLOON CATHETER— 510(k) K140273
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K140273 for EQUALIZER OCCLUSION BALLOON CATHETER, Substantially Equivalent on 2014-07-22. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code MJN
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- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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.