Avd Intimax Cholangiography Catheter
FDA 510(k) K910493 · Applied Vascular Devices, Inc.
510(k) numberK910493
Submission
- Device name
- Avd Intimax Cholangiography Catheter
- Applicant
- Applied Vascular Devices, Inc.
Laguna Hills, CA, US - Received
- February 5, 1991
- Decision date
- March 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K911730 | Surgical Obturator with SealGCJ · Traditional | 12/23/1991SE |
| K911589 | Disposable Surgical Trocar with SealGCJ · Traditional | 07/05/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | 05/29/1991SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | 04/26/1991SE |
| K911181 | Intimax(Tm) Irrigation CatheterGCA · Traditional | 04/18/1991SE |
| K903848 | Diagnostic Intrascular CatheterDQO · Traditional | 03/25/1991SE |
| K905738 | Operative Cholangiographic CatheterFGE · Traditional | 03/21/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | 02/27/1991SE |
| K902256 | Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional | 02/15/1991SE |
| K904379 | Surgical Trocar and CannulaHET · Traditional | 12/21/1990SE |
Questions and answers
When was Avd Intimax Cholangiography Catheter cleared by the FDA?
Avd Intimax Cholangiography Catheter (K910493) received a 510(k) decision of Substantially Equivalent on March 28, 1991, 51 days after the submission was received.
What is the product code of K910493?
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.