Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter
FDA 510(k) K133130 · Cook, Inc.
510(k) numberK133130
Submission
- Device name
- Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- September 30, 2013
- Decision date
- January 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter cleared by the FDA?
Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter (K133130) received a 510(k) decision of Substantially Equivalent on January 9, 2015, 466 days after the submission was received.
What is the product code of K133130?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.