TSI Transseptal Introducer— 510(k) K181031
Substantially EquivalentPressure Products Medical Device Manufacturing, LLC
FDA 510(k) clearance K181031 for TSI Transseptal Introducer, Substantially Equivalent on 2018-10-26. Applicant: Pressure Products Medical Device Manufacturing, LLC.
Clearance details
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Product code
- Code DYB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morton, PA, US
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.