Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
FDA 510(k) K173709 · Inneuroco, Inc.
510(k) numberK173709
Submission
- Device name
- Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- December 4, 2017
- Decision date
- January 26, 2018
- 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 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm cleared by the FDA?
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (K173709) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 53 days after the submission was received.
What is the product code of K173709?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.