The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Pta 14 Balloon Dilatation Catheter Otw.
| Device ID | K142954 |
| 510k Number | K142954 |
| Device Name: | PTA 14 Balloon Dilatation Catheter OTW |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Texas Medical Technologies, Inc. 9005 Montana Ave., Suite A El Paso, TN 79925 |
| Contact | Aaron Chiu |
| Correspondent | Viviana I Gonzalez Pomamed Consulting LLC PO Box 9818 San Juan, PR 00908 -0818 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2015-05-28 |
| Summary: | summary |