PTA 14 Balloon Dilatation Catheter OTW
FDA 510(k) K142954 · Texasmedical Technologies, Inc.
510(k) numberK142954
Submission
- Device name
- PTA 14 Balloon Dilatation Catheter OTW
- Applicant
- Texasmedical Technologies, Inc.
El Paso, TN, US - Received
- October 10, 2014
- Decision date
- May 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K170915 | TXM Hydrophilic GuidewireDQX · Traditional | 11/21/2017SE |
| K170914 | TXM Support CatheterDQY · Traditional | 11/21/2017SE |
| K153771 | TXM Guiding SheathDYB · Traditional | 09/13/2016SE |
| K153703 | Guiding CatheterDQY · Traditional | 05/12/2016SE |
| K153125 | IntraNovo MicrocatheterDQO · Special | 01/13/2016SE |
| K142817 | IntraNovo 25 MicrocatheterDQO · Traditional | 04/23/2015SE |
Questions and answers
When was PTA 14 Balloon Dilatation Catheter OTW cleared by the FDA?
PTA 14 Balloon Dilatation Catheter OTW (K142954) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 230 days after the submission was received.
What is the product code of K142954?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.