Bard Memotherm Covered Esophageal Stent, Model Multiple
FDA 510(k) K002094 · C.R. Bard, Inc.
510(k) numberK002094
Submission
- Device name
- Bard Memotherm Covered Esophageal Stent, Model Multiple
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- July 11, 2000
- Decision date
- October 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ESW – Prosthesis, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code ESW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | Boston Scientific Corporation | 07/10/2026SE |
| K253327 | HANAROSTENT Esophagus Upper (CCC)ESW · Special | M.I.Tech Co., Ltd. | 10/30/2025SE |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | Taewoong Medical Co., Ltd. | 10/30/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | Merit Medical Systems, Inc. | 07/23/2025SE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional | Boston Scientific | 04/29/2024SE |
| K233837 | Agile Esophageal Stent SystemESW · Traditional | Boston Scientific Corporation | 04/04/2024SE |
| K240522 | Esophageal TTS StentESW · Special | Taewoong Medical | 03/22/2024SE |
| K223266 | Hilzo Esophageal StentsESW · Traditional | Thoracent, Inc. | 01/16/2024SE |
| K221482 | Esophageal TTS StentESW · Special | Taewoong Medical Co., Ltd. | 06/22/2022SE |
| K211960 | Agile Esophageal OTW Stent SystemESW · Traditional | Boston Scientific Corporation | 11/22/2021SE |
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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
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| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Bard Memotherm Covered Esophageal Stent, Model Multiple cleared by the FDA?
Bard Memotherm Covered Esophageal Stent, Model Multiple (K002094) received a 510(k) decision of Substantially Equivalent on October 6, 2000, 87 days after the submission was received.
What is the product code of K002094?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.