VPS Rhythm Device with TipTracker Technology— 510(k) K160925
Substantially EquivalentArrow International, Inc. (A Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K160925 for VPS Rhythm Device with TipTracker Technology, Substantially Equivalent on 2016-12-22. Applicant: Arrow International, Inc. (A Subsidiary of Teleflex, Inc.).
Clearance details
- Applicant
- Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.