Modification to Paramount Mini Stent and Delivery System
FDA 510(k) K033134 · Ev3, Inc.
510(k) numberK033134
Submission
- Device name
- Modification to Paramount Mini Stent and Delivery System
- Applicant
- Ev3, Inc.
Plymouth, MN, US - Received
- September 30, 2003
- Decision date
- November 17, 2003
- Decision
- Unknown (SESU)
- Type
- Special 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
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|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | 01/05/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
Questions and answers
When was Modification to Paramount Mini Stent and Delivery System cleared by the FDA?
Modification to Paramount Mini Stent and Delivery System (K033134) received a 510(k) decision of Unknown on November 17, 2003, 48 days after the submission was received.
What is the product code of K033134?
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.