Powercross .018 Otw Pta Dilation Catheter
FDA 510(k) K093286 · Ev3, Inc.
510(k) numberK093286
Submission
- Device name
- Powercross .018 Otw Pta Dilation Catheter
- Applicant
- Ev3, Inc.
Plymouth, MN, US - Received
- October 20, 2009
- Decision date
- November 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | 01/05/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
Questions and answers
When was Powercross .018 Otw Pta Dilation Catheter cleared by the FDA?
Powercross .018 Otw Pta Dilation Catheter (K093286) received a 510(k) decision of Substantially Equivalent on November 13, 2009, 24 days after the submission was received.
What is the product code of K093286?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.