R-Group International Coiled Low Pressure Extension Line
FDA 510(k) K940319 · R-Group Intl.
510(k) numberK940319
Submission
- Device name
- R-Group International Coiled Low Pressure Extension Line
- Applicant
- R-Group Intl.
Gainesville, FL, US - Received
- January 24, 1994
- Decision date
- November 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001233 | Acti-Flex Fluid Delivery System or Acti-Flex F D SFPA · Traditional | 12/13/2000SE |
| K001599 | Acti-Flex IV Administration SetFPA · Traditional | 09/18/2000SE |
| K993777 | Disposable and Reusable Ball and Loop ElectrodesHGI · Traditional | 05/25/2000SE |
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | 11/28/1995SE |
| K954035 | Acti-Flex Arterial Extension SetCBT · Traditional | 09/25/1995SE |
| K913267 | R-Group Intl. One Wall Puncture NeedleDRC · Traditional | 06/05/1992SE |
Questions and answers
When was R-Group International Coiled Low Pressure Extension Line cleared by the FDA?
R-Group International Coiled Low Pressure Extension Line (K940319) received a 510(k) decision of Substantially Equivalent on November 10, 1994, 290 days after the submission was received.
What is the product code of K940319?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.