Mini Spike Plus 6/8R
FDA 510(k) K201469 · B.Braun Medical, Inc.
510(k) numberK201469
Submission
- Device name
- Mini Spike Plus 6/8R
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- June 3, 2020
- Decision date
- December 9, 2020
- 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 Mini Spike Plus 6/8R cleared by the FDA?
Mini Spike Plus 6/8R (K201469) received a 510(k) decision of Substantially Equivalent on December 9, 2020, 189 days after the submission was received.
What is the product code of K201469?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.