Rusch Brillant Balloon Catheter
FDA 510(k) K971643 · Rusch Intl.
510(k) numberK971643
Submission
- Device name
- Rusch Brillant Balloon Catheter
- Applicant
- Rusch Intl.
Jeffrey, NH, US - Received
- May 5, 1997
- Decision date
- October 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033023 | Intermittent Urethral CathetersKOD · Traditional | 12/23/2003SE |
| K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemESW · Traditional | 06/30/2003SE |
| K023666 | Rusch Guided Cholangiography CatheterFGE · Traditional | 06/17/2003SE |
| K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessJOH · Traditional | 03/28/2003SE |
| K023964 | Rusch Microlaryngeal TubeBTR · Traditional | 12/23/2002SE |
| K021540 | Rusch Edgar TubeBTR · Traditional | 08/01/2002SE |
| K021764 | Rusch Tracheofix Set, Cuffed and UncuffedBTO · Traditional | 07/23/2002SE |
| K020714 | Rusch Floneil; Flocath IntrogelGBM · Traditional | 07/01/2002SE |
| K010798 | Rusch Cantor TubeKNT · Traditional | 02/26/2002SE |
| K010797 | Rusch Miller-Abbott TubeKNT · Traditional | 02/26/2002SE |
Questions and answers
When was Rusch Brillant Balloon Catheter cleared by the FDA?
Rusch Brillant Balloon Catheter (K971643) received a 510(k) decision of Substantially Equivalent on October 7, 1997, 155 days after the submission was received.
What is the product code of K971643?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.