072 Aspiration System
The 072 Aspiration Catheter is a single-lumen, variable-stiffness catheter used with a compatible suction pump for stroke revascularization. A hydrophilic coating reduces friction, distal…
The 072 Aspiration Catheter is a single-lumen, variable-stiffness catheter used with a compatible suction pump for stroke revascularization. A hydrophilic coating reduces friction, distal radiopaque markers support angiographic positioning, and a proximal Luer hub permits flushing or aspiration connections.
Use is indicated for acute ischemic stroke from large-vessel occlusion within the internal carotid, middle cerebral M1 or M2, basilar or vertebral arteries within eight hours of symptom onset. Candidates include patients ineligible for intravenous t-PA or whose t-PA therapy failed.
Listed Item
As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
Aspiration Connections
The catheter package includes a delivery tool, rotating hemostasis valve and flow switch. Aspiration tubing is supplied separately to connect a suction pump meeting the specified performance parameters. The optional delivery tool must be removed before aspiration, separating its delivery-support function from the aspiration pathway.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Q’apel Medical, Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer |
| 510(k) | K222786 |
| Record published | 2023-10-11 |
| Record revised | 2025-05-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 01252 | Withdrawn | |
| FG 00806 | Withdrawn | |
| FG 00995 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254276 | 2026-05-07 |
| K222786 | 2023-08-25 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Q’apel Medical, Inc. | 510(k) number | 2025-02-26 | Class I | Device Design | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. | 1617 |
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.