INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR— 510(k) K931278
Substantially EquivalentInterventional Therapeutics Corp.
FDA 510(k) clearance K931278 for INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR, Substantially Equivalent on 1993-07-23. Applicant: Interventional Therapeutics Corp.. Device class: 2.
Clearance details
- Applicant
- Interventional Therapeutics Corp.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Interventional Therapeutics Corp.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.