CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS— 510(k) K120158
Substantially EquivalentThomas Medical Products, Inc.
FDA 510(k) clearance K120158 for CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS, Substantially Equivalent on 2012-08-14. Applicant: Thomas Medical Products, Inc..
Clearance details
- Applicant
- Thomas Medical Products, Inc.
- Product code
- Code DYB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, 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.