Cxi Support Catheter
FDA 510(k) K122796 · Cook, Inc.
510(k) numberK122796
Submission
- Device name
- Cxi Support Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- September 12, 2012
- Decision date
- October 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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Questions and answers
When was Cxi Support Catheter cleared by the FDA?
Cxi Support Catheter (K122796) received a 510(k) decision of Substantially Equivalent on October 11, 2012, 29 days after the submission was received.
What is the product code of K122796?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.