Envoy Guiding Catheter
FDA 510(k) K140307 · Codman & Shurtleff, Inc.
510(k) numberK140307
Submission
- Device name
- Envoy Guiding Catheter
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- February 7, 2014
- Decision date
- April 21, 2014
- 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 Envoy Guiding Catheter cleared by the FDA?
Envoy Guiding Catheter (K140307) received a 510(k) decision of Substantially Equivalent on April 21, 2014, 73 days after the submission was received.
What is the product code of K140307?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.