510(k) K142954
K142954 is an FDA 510(k) premarket notification submitted by Texasmedical Technologies, Inc. for the device "PTA 14 Balloon Dilatation Catheter OTW". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Texasmedical Technologies, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2015
- Date Received
- Oct 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)