SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020— 510(k) K041818
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K041818 for SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020, Substantially Equivalent on 2004-11-10. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fremont, CA, US
Recent devices under product code ITX
view allMore clearances from Boston Scientific Corp
view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- 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 ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.