BD PureHub Disinfecting Cap
FDA 510(k) K193190 · Becton, Dickinson and Company
510(k) numberK193190
Submission
- Device name
- BD PureHub Disinfecting Cap
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- November 19, 2019
- Decision date
- November 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBP – Cap, Device Disinfectant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
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Questions and answers
When was BD PureHub Disinfecting Cap cleared by the FDA?
BD PureHub Disinfecting Cap (K193190) received a 510(k) decision of Substantially Equivalent on November 9, 2020, 356 days after the submission was received.
What is the product code of K193190?
The FDA product code is QBP – Cap, Device Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 880.5440.