510(k) K153771
K153771 is an FDA 510(k) premarket notification submitted by Texasmedical Technologies, Inc. for the device "TXM Guiding Sheath". The FDA issued a decision of Substantially Equivalent on Sep 13, 2016. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Texasmedical Technologies, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 2016
- Date Received
- Dec 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)