Zoom 7x Catheter
The Zoom 7X Catheter removes clot from brain arteries when connected to a compatible aspiration pump through Zoom or Zoom POD tubing. It is used for acute ischemic stroke caused by large…
The Zoom 7X Catheter removes clot from brain arteries when connected to a compatible aspiration pump through Zoom or Zoom POD tubing. It is used for acute ischemic stroke caused by large vessel occlusion within eight hours of last known well. Candidates cannot receive intravenous thrombolytic therapy or have not responded to it.
The single channel catheter uses a reinforced, variable stiffness shaft and a hydrophilic distal coating. Its preshaped beveled tip and radiopaque marker support placement under fluoroscopy. The proximal luer fitting connects the catheter to the aspiration pathway.
Listed Item
Zoom 7X Catheter, 137cm
Anatomical and Supply Scope
The indicated vessels are the internal carotid, middle cerebral M1 and M2, basilar and vertebral arteries. The catheter has a 137 centimetre working length and is supplied sterile for a single use, with a rotating hemostasis valve and introducer sheaths.
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 | Imperative Care Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K243047 |
| Record published | 2025-06-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry. Keep away from sunlight. Store at room temperature. |
| Sizes | Lumen/inner diameter 0.071 in; outer diameter 0.083 in; catheter length 137 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICRC07X137 | Lumen/Inner Diameter 0.071 in | In distribution |
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 |
|---|---|
| K252046 | 2025-10-30 |
| K243047 | 2025-05-28 |
| K242672 | 2025-01-14 |
| K211476 | 2021-06-08 |
| K210996 | 2021-04-23 |
| K202182 | 2020-09-02 |
| K183043 | 2019-04-17 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-08-13 | Class I | Under Investigation by firm | There is a potential for distal end of catheters to fracture and become detached. | 3118 units |
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.