FLOCATH
FDA 510(k) clearance K000070 · decided 2000-02-18
Clearance details
- K-number
- K000070
- Device name
- FLOCATH
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-10
- Decision date
- 2000-02-18
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Rese recall (Z-1732-2014) | Teleflex Medical | 2014-06-09 |