Thruport Systems Intraclude Intra-Aortic Occlusion Device
The IntraClude Intra-Aortic Occlusion Device is a balloon catheter used during cardiopulmonary bypass. Inflation of its distal balloon occludes the ascending aorta, separating the aortic…
The IntraClude Intra-Aortic Occlusion Device is a balloon catheter used during cardiopulmonary bypass. Inflation of its distal balloon occludes the ascending aorta, separating the aortic root from the arterial circulation. It is introduced through a femoral approach with an Edwards arterial cannula or introducer sheath.
Its central lumen accommodates a guidewire, delivers cardioplegia solution to the aortic root and vents fluid and air. Two additional lumens provide balloon inflation and deflation and aortic root pressure monitoring.
Listed Item
Intraclude Intra-Aortic Occlusion Device
Catheter Configuration
The catheter is 100 cm long and has a balloon designed for aortic diameters of 20 to 40 mm. Depth markers indicate insertion distance, and locking components secure its position. It is supplied sterile and nonpyrogenic for single use.
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K132175 |
| Record published | 2016-08-31 |
| Record revised | 2023-12-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICF100 | 10.5 FR. (3.5 MM) X 39.4″ (100 CM) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 831 |
| Novo Surgical | Novo Surgical, Inc. | 708 |
| Ambler Surgical | Ambler Surgical, LLC | 575 |
| Pilling | Teleflex Medical LLC | 544 |
| Avalign | Avalign Technologies, Inc. | 543 |
| Boss Instruments | Boss Instruments, Ltd. | 457 |
| V. Mueller | Steris Corporation | 432 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 342 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 331 |
| Scanlan® | Scanlan International, Inc. | 294 |
| HNM Medical | HNM Stainless, LLC. | 230 |
| Aesculap | Aesculap AG | 136 |
Showing 12 of 639. All products under Clamp, Vascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260105 | 2026-06-05 |
| K163693 | 2017-01-26 |
| K132175 | 2013-09-13 |
| K113182 | 2011-12-07 |
| K112694 | 2011-10-14 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2019-05-14 | Class I | Device Design | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative s | 6552 | 2024-04-23 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2019-01-16 | Class II | Process control | Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device. | 2715 units | |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2018-03-30 | Class II | Under Investigation by firm | Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta. | 3,052 units total | 2023-11-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2015-05-05 | Class II | Device Design | Potential device damage on the strain relief near the hub area, which may result in blood leakage. | 3,360 units. | 2017-12-12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-09-24 | Not classified | Process control | Balloon catheters were spontaneously rupturing during use. | 2,737 total | 2012-04-25 |
| 2009-09-24 | Not classified | Process control | Spontaneous balloon rupture during use of the product. | 2,737 total | 2012-04-25 |
| 2008-11-26 | Not classified | Nonconforming Material/Component | Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. | 1267 units | 2011-08-10 |
| 2008-11-26 | Not classified | Nonconforming Material/Component | Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173. | 963 units | 2011-08-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.