Needleless Connector
FDA 510(k) K210217 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK210217
Submission
- Device name
- Needleless Connector
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- January 27, 2021
- Decision date
- May 17, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…JKA · Traditional | 09/09/2020SE |
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Questions and answers
When was Needleless Connector cleared by the FDA?
Needleless Connector (K210217) received a 510(k) decision of Substantially Equivalent on May 17, 2021, 110 days after the submission was received.
What is the product code of K210217?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.