YOGA Microcatheter
FDA 510(k) K162563 · Codman & Shurtleff, Inc.
510(k) numberK162563
Submission
- Device name
- YOGA Microcatheter
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- September 14, 2016
- Decision date
- January 5, 2017
- 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 YOGA Microcatheter cleared by the FDA?
YOGA Microcatheter (K162563) received a 510(k) decision of Substantially Equivalent on January 5, 2017, 113 days after the submission was received.
What is the product code of K162563?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.