Nipro Needleless Transfer Device, Models: M285503 and M285505
FDA 510(k) K092246 · Nipro Medical Corporation
510(k) numberK092246
Submission
- Device name
- Nipro Needleless Transfer Device, Models: M285503 and M285505
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- July 28, 2009
- Decision date
- November 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Nipro Needleless Transfer Device, Models: M285503 and M285505 cleared by the FDA?
Nipro Needleless Transfer Device, Models: M285503 and M285505 (K092246) received a 510(k) decision of Substantially Equivalent on November 12, 2009, 107 days after the submission was received.
What is the product code of K092246?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.