DISPOSABLE INFUSION SET— 510(k) K090012
Substantially EquivalentShan Dong Wei Gao Group Medical Polymer Products
FDA 510(k) clearance K090012 for DISPOSABLE INFUSION SET, Substantially Equivalent on 2009-06-11. Applicant: Shan Dong Wei Gao Group Medical Polymer Products. Device class: 2.
Clearance details
- Applicant
- Shan Dong Wei Gao Group Medical Polymer Products
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shan Nan Er Rd., Shanghai, CN
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Shan Dong Wei Gao Group Medical Polymer Products
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 K090012
K-number listed on FDA's recall record- Z-1277-2015 — Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
- Z-2179-2012 — Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090012.
Data sourced from openFDA. This site is unofficial and independent of the FDA.