510(k) K173709
K173709 is an FDA 510(k) premarket notification submitted by Inneuroco, Inc. for the device "Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm". The FDA issued a decision of Substantially Equivalent on January 26, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Inneuroco, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2018
- Date Received
- December 4, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type