Torcon NB Advantage Catheters
FDA 510(k) K161822 · Cook Incorporated
510(k) numberK161822
Submission
- Device name
- Torcon NB Advantage Catheters
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- July 1, 2016
- Decision date
- October 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Torcon NB Advantage Catheters cleared by the FDA?
Torcon NB Advantage Catheters (K161822) received a 510(k) decision of Substantially Equivalent on October 27, 2016, 118 days after the submission was received.
What is the product code of K161822?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.