R-Group Intl. One Wall Puncture Needle
FDA 510(k) K913267 · R-Group Intl.
510(k) numberK913267
Submission
- Device name
- R-Group Intl. One Wall Puncture Needle
- Applicant
- R-Group Intl.
Gainesville, FL, US - Received
- July 23, 1991
- Decision date
- June 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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|---|---|---|
| K001233 | Acti-Flex Fluid Delivery System or Acti-Flex F D SFPA · Traditional | 12/13/2000SE |
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| 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 |
| K940319 | R-Group International Coiled Low Pressure Extension LineFPA · Traditional | 11/10/1994SE |
Questions and answers
When was R-Group Intl. One Wall Puncture Needle cleared by the FDA?
R-Group Intl. One Wall Puncture Needle (K913267) received a 510(k) decision of Substantially Equivalent on June 5, 1992, 318 days after the submission was received.
What is the product code of K913267?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.