INTRACOIL STENT— 510(k) K001257
Substantially EquivalentIntratherapeutics, Inc.
FDA 510(k) clearance K001257 for INTRACOIL STENT, Substantially Equivalent on 2000-05-18. Applicant: Intratherapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intratherapeutics, Inc.
- Product code
- Code JCT
- Device class
- Class 2
- Regulation
- 21 CFR 878.3720
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint Paul, MN, US
Recent devices under product code JCT
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- K003450 — INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
- K001648 — INTRASTENT DOUBLESTRUT PARAMOUNT
Adverse events under product code JCT
product code JCT- Death
- 20
- Injury
- 211
- Other
- 1
- Total
- 232
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.