ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668— 510(k) K001413
Substantially Equivalent - Subject to Tracking Reg.Biotronik, Inc.
FDA 510(k) clearance K001413 for ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668, Substantially Equivalent - Subject to Tracking Reg. on 2000-06-02. Applicant: Biotronik, Inc..
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Special
- Location
- Lake Oswego, OR, US
Adverse events under product code DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
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.