DILATATION CATHETER, BALLOON— 510(k) K952968
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K952968 for DILATATION CATHETER, BALLOON, Substantially Equivalent on 1995-08-10. Applicant: Boston Scientific Corp. Device class: Unclassified.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick,, MA, US
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More clearances from Boston Scientific Corp
view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
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- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
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.