510(k) K170958
K170958 is an FDA 510(k) premarket notification submitted by Tricol Biomedical, Inc. for the device "ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm". The FDA issued a decision of Substantially Equivalent on Aug 29, 2017. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 2017
- Date Received
- Mar 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type
- 510(k)