IMAGER TORQUE CATHETER— 510(k) K965229
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K965229 for IMAGER TORQUE CATHETER, Substantially Equivalent on 1997-03-04. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick,, MA, US
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- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
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.