Dural-Lumen Intra Vascular Balloon Catheter (Modification)
FDA 510(k) K954713 · Ideas For Medicine, Inc.
510(k) numberK954713
Submission
- Device name
- Dural-Lumen Intra Vascular Balloon Catheter (Modification)
- Applicant
- Ideas For Medicine, Inc.
Clearwater, FL, US - Received
- October 10, 1995
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
More from Softac Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K961883 | Versa-Cath Arterial CatheterDXE · Traditional | 01/13/1997SE |
| K962751 | Ideas' Dual PortLJT · Traditional | 09/30/1996SE |
| K961716 | Vaso-Safe Arterial Embolectomy CatheteDXE · Traditional | 09/19/1996SE |
| K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/INAHARA-PRUITT Carotid Shunt 500-50-8FMJN · Traditional | 09/09/1996SE |
| K960422 | Pruitt Safety Occlusion CatheterMJN · Traditional | 08/07/1996SE |
| K935964 | Ideas OccluderDXC · Traditional | 01/04/1995SE |
| K935023 | Godat Uterine Manipulator InjectorLKF · Traditional | 01/04/1995SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | 05/25/1988SE |
| K872090 | The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional | 10/30/1987SE |
| K872485 | Change of Catheter Body Material (Radio-Opaque Ny)DXE · Traditional | 08/12/1987SE |
Questions and answers
When was Dural-Lumen Intra Vascular Balloon Catheter (Modification) cleared by the FDA?
Dural-Lumen Intra Vascular Balloon Catheter (Modification) (K954713) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 288 days after the submission was received.
What is the product code of K954713?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.