ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210996 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
- Models / Variants
- ZOOM (71, 55, 45, 35) Reperfusion Catheters FDA 510(k)ZOOM Aspiration Tubing FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ZOOM (71, 55, 45, 35) Reperfusion Catheters are designed as catheters, thrombus retrievers for mechanical thrombectomy, intended to remove occlusive thrombi from intracranial arteries. These devices are engineered to facilitate revascularization in patients with acute ischemic stroke caused by large vessel occlusion, targeting segments such as the internal carotid, middle cerebral (M1/M2), basilar, and vertebral arteries. Their asymmetric tip design enhances clot engagement, improving clot retrieval efficiency during endovascular procedures.
These catheters are supplied as single-use, non-sterile devices and are paired with aspiration tubing for use with a vacuum pump. They are classified as Class II medical devices under FDA regulation 870.1250 and have received FDA 510(k) clearance via a Special 510(k) pathway. The device sizes (71, 55, 45, 35) correspond to outer diameters matched to specific vessel calibers, ensuring compatibility with a range of anatomical variations. Storage and handling must comply with sterile processing protocols prior to use in clinical settings.
Frequently asked questions
What is the ZOOM (71, 55, 45, 35) Reperfusion Catheter used for?
The ZOOM Reperfusion Catheters are designed specifically for mechanical thrombectomy to remove occlusive thrombi from intracranial arteries during acute ischemic stroke procedures. Their asymmetric tip enhances clot engagement, improving retrieval efficiency in critical vessels like the internal carotid, middle cerebral (M1/M2), basilar, and vertebral arteries. This targeted approach helps restore blood flow in patients with large vessel occlusions.
How are the ZOOM Reperfusion Catheters supplied and prepared for use?
The ZOOM Reperfusion Catheters are supplied as single-use, non-sterile devices. They must be sterilized using appropriate sterile processing protocols prior to clinical use, as per standard medical device handling guidelines. The catheters are paired with ZOOM Aspiration Tubing and require a vacuum pump for operation.
What sizes are available for the ZOOM Reperfusion Catheters, and how do they relate to vessel compatibility?
The ZOOM Reperfusion Catheters come in four sizes: 71, 55, 45, and 35, corresponding to outer diameters matched to specific vessel calibers. These sizes ensure compatibility with a range of anatomical variations, allowing clinicians to select the appropriate catheter for the targeted intracranial artery during thrombectomy procedures.
Are the ZOOM Reperfusion Catheters reusable, or are they intended for single-use?
The ZOOM Reperfusion Catheters are explicitly designed for single-use only. This design choice aligns with best practices for minimizing infection risks and ensuring device performance consistency during critical procedures like thrombectomy.
What regulatory pathway was followed for the ZOOM Reperfusion Catheters?
The ZOOM Reperfusion Catheters received FDA 510(k) clearance through the Special 510(k) pathway, demonstrating substantial equivalence to a predicate device. They are classified as Class II medical devices under FDA regulation 870.1250, reflecting their role in mechanical thrombectomy for acute ischemic stroke.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Zoom Aspiration Catheters - Imperative Care, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210996 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imperative Care, Inc.
Sources (1)
- FDA 510(k) K210996 24 fields · synced Oct 6, 2026