FLOCATH— 510(k) K000070
Substantially EquivalentRusch Intl.
FDA 510(k) clearance K000070 for FLOCATH, Substantially Equivalent on 2000-02-18. Applicant: Rusch Intl.. Device class: 2.
Clearance details
- Applicant
- Rusch Intl.
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jeffrey, NH, US
Recent devices under product code KOD
view allMore clearances from Rusch Intl.
view allAdverse 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 →
Recalls naming K000070
K-number listed on FDA's recall record- Z-2086-2019 — Rusch EasyCath Kit
- Z-1732-2014 — RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000070.
Data sourced from openFDA. This site is unofficial and independent of the FDA.