VPS Rhythm DLX Device with TipTracker Technology— 510(k) K220363
Substantially EquivalentArrow International, LLC (A subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K220363 for VPS Rhythm DLX Device with TipTracker Technology, Substantially Equivalent on 2022-08-22. Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International, LLC (A subsidiary of Teleflex, Inc.)
- Product code
- Product code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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More clearances from Arrow International, LLC (A subsidiary of Teleflex, Inc.)
view allAdverse 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.