DISPOSABLE INFUSION SET
FDA 510(k) clearance K090012 · decided 2009-06-11
Clearance details
- K-number
- K090012
- Device name
- DISPOSABLE INFUSION SET
- Applicant
- Shan Dong Wei Gao Group Medical Polymer Products
- Decision
- Substantially Equivalent
- Date received
- 2009-01-02
- Decision date
- 2009-06-11
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shan Nan Er Rd., Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set w recall (Z-1277-2015) | US Infusion Inc dba Trucare Biomedix-USA | 2015-03-13 |
| Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Ste recall (Z-2179-2012) | Medical Specialties Distributors, Inc. | 2012-08-09 |