Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter— 510(k) K181979
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K181979 for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter, Substantially Equivalent on 2019-05-24. Applicant: Teleflexmedical, Inc..
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code KOD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
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.