Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
FDA 510(k) K172777 · PAJUNK GmbH Medizintechnologie
510(k) numberK172777
Submission
- Device name
- Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- September 14, 2017
- Decision date
- May 3, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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Questions and answers
When was Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 cleared by the FDA?
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (K172777) received a 510(k) decision of Substantially Equivalent on May 3, 2018, 231 days after the submission was received.
What is the product code of K172777?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.