510(k) K192691— PatCom Single-Use Introducer
Substantially EquivalentH&A Mui Enterprises, Inc.
Clearance details
- Applicant
- H&A Mui Enterprises, Inc.
- Product code
- Code FED
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Adverse events under product code FED
product code FED- Death
- 10
- Total
- 10
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.