065 Zenith, 074 Zenith
FDA 510(k) K171672 · Inneuroco, Inc.
510(k) numberK171672
Submission
- Device name
- 065 Zenith, 074 Zenith
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- June 6, 2017
- Decision date
- October 19, 2017
- 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 065 Zenith, 074 Zenith cleared by the FDA?
065 Zenith, 074 Zenith (K171672) received a 510(k) decision of Substantially Equivalent on October 19, 2017, 135 days after the submission was received.
What is the product code of K171672?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.