MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT— 510(k) K030855
UnknownBoston Scientific Corp
FDA 510(k) clearance K030855 for MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT, Unknown on 2003-04-17. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Natick,, MA, US
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Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.