ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS— 510(k) K884811
Substantially EquivalentTelectronics and Control Pacing Systems
FDA 510(k) clearance K884811 for ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS, Substantially Equivalent on 1989-02-22. Applicant: Telectronics and Control Pacing Systems.
Clearance details
- Applicant
- Telectronics and Control Pacing Systems
- Product code
- Code DTB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, 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.