NIPRO SAFETOUCH HUBER INFUSTION SET
FDA 510(k) clearance K081210 · decided 2008-10-21
Clearance details
- K-number
- K081210
- Device name
- NIPRO SAFETOUCH HUBER INFUSTION SET
- Applicant
- Nipro Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-29
- Decision date
- 2008-10-21
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37 recall (Z-0639-2010) | Exelint International Co. | 2010-01-22 |