EQUINOX Balloon Dilatation Catheter
FDA 510(k) K190612 · Dornier Medtech America, Inc.
510(k) numberK190612
Submission
- Device name
- EQUINOX Balloon Dilatation Catheter
- Applicant
- Dornier Medtech America, Inc.
Kennesaw, GA, US - Received
- March 11, 2019
- Decision date
- December 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZN – Dilator, Catheter, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5470
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation CatheterEZN · Traditional | Urotronic, Inc. | 05/22/2025SE |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal…EZN · Traditional | Allwin Medical Devices, Inc. | 05/05/2023SE |
| K201007 | In-Ka Ureteral Balloon Dilatation CatheterEZN · Traditional | Coloplast Corp. | 06/11/2020SESK |
| K173654 | Ureteral Dilator Sets, Ureteral DilatorsEZN · Traditional | Cook Incorporated | 07/17/2018SE |
| K180756 | Safety Wire Guide IntroducerEZN · Traditional | Cook Incorporated | 05/24/2018SE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer SetEZN · Traditional | Cook Incorporated | 05/02/2018SE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator SetEZN · Traditional | Cook Incorporated | 04/19/2018SESK |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN · Traditional | Coloplast Corp. | 08/17/2017SE |
| K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterEZN · Traditional | Olympus Surgical Technologies America | 10/21/2013SE |
| K130804 | Uromax Ultra Balloon Dilatation CatheterEZN · Traditional | Boston Scientific Corporation | 05/22/2013SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…FED · Traditional | 01/31/2025SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | 06/26/2024SE |
| K221903 | Delta III ProLNS · Traditional | 02/22/2023SE |
| K213252 | Dornier ThulioGEX · Traditional | 07/27/2022SE |
| K220871 | NautilusJAA · Special | 04/18/2022SE |
| K210394 | Electrosurgical accessoryFAS · Traditional | 05/19/2021SE |
| K201815 | Dornier MAGELLAN Ureteral Access SheathFED · Traditional | 11/20/2020SE |
| K201074 | Delta III LithotripterLNS · Traditional | 09/03/2020SE |
| K190312 | Dornier Ureteral StentFAD · Traditional | 11/15/2019SE |
| K191187 | Dornier MINNOW Ureteral CatheterEYB · Traditional | 09/18/2019SE |
Questions and answers
When was EQUINOX Balloon Dilatation Catheter cleared by the FDA?
EQUINOX Balloon Dilatation Catheter (K190612) received a 510(k) decision of Substantially Equivalent on December 6, 2019, 270 days after the submission was received.
What is the product code of K190612?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.