ACTI-FLEX IV ADMINISTRATION SET
FDA 510(k) clearance K001599 · decided 2000-09-18
Clearance details
- K-number
- K001599
- Device name
- ACTI-FLEX IV ADMINISTRATION SET
- Applicant
- R-Group Intl.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-24
- Decision date
- 2000-09-18
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extens recall (Z-1996-2014) | RGI Medical Manufacturing, Inc. | 2014-07-07 |