ADROIT Guiding Catheter
FDA 510(k) K143412 · Cordis Corporation
510(k) numberK143412
Submission
- Device name
- ADROIT Guiding Catheter
- Applicant
- Cordis Corporation
Fremont, CA, US - Received
- November 28, 2014
- Decision date
- January 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was ADROIT Guiding Catheter cleared by the FDA?
ADROIT Guiding Catheter (K143412) received a 510(k) decision of Substantially Equivalent on January 14, 2015, 47 days after the submission was received.
What is the product code of K143412?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.