Silk Road Acccess Catheter
FDA 510(k) K143459 · Silk Road Medical, Inc.
510(k) numberK143459
Submission
- Device name
- Silk Road Acccess Catheter
- Applicant
- Silk Road Medical, Inc.
Sunnyvale, CA, US - Received
- December 4, 2014
- Decision date
- April 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Silk Road Acccess Catheter cleared by the FDA?
Silk Road Acccess Catheter (K143459) received a 510(k) decision of Substantially Equivalent on April 1, 2015, 118 days after the submission was received.
What is the product code of K143459?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.