Absolute Pro .035 Self-Expanding Stent System
FDA 510(k) K072708 · Abbott Vascular-Vascular Solutions
510(k) numberK072708
Submission
- Device name
- Absolute Pro .035 Self-Expanding Stent System
- Applicant
- Abbott Vascular-Vascular Solutions
Santa Clara, CA, US - Received
- September 25, 2007
- Decision date
- August 18, 2008
- Decision
- Unknown (SESU)
- 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 |
|---|---|---|
| K090665 | Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19NTE · Special | 05/22/2009SE |
| K090509 | Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta…DQY · Special | 03/20/2009SE |
| K081523 | Emboshield NAV6 Embolic Protection SystemNTE · Traditional | 09/11/2008SE |
| K080264 | Modification to: Fox Plus Pta CatheterLIT · Special | 03/26/2008SE |
| K072798 | Viatrac 14 Plus Peripheral Dilation CatheterLIT · Traditional | 01/31/2008SE |
Questions and answers
When was Absolute Pro .035 Self-Expanding Stent System cleared by the FDA?
Absolute Pro .035 Self-Expanding Stent System (K072708) received a 510(k) decision of Unknown on August 18, 2008, 328 days after the submission was received.
What is the product code of K072708?
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.