Caterpillar and Caterpillar Micro Arterial Embolization Devices
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191532 FDA 510(k)
- FDA Product Code
- KRD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3300 FDA 510(k)
- Regulation Number
- 870.3300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Caterpillar and Caterpillar Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs designed for vascular embolization. These devices permanently occlude blood vessels in the peripheral vasculature, utilizing a cobalt-chrome stem, nickel-titanium fibers, and radiopaque marker bands for precise placement and visibility under imaging. They are classified under the nomenclature for vascular devices intended to promote embolization.
The devices are supplied as single-use, permanent implants and are intended for use in interventional radiology or vascular surgery settings. They are not MRI-safe and must be handled with sterile techniques. Available in multiple sizes and configurations, they are regulated under FDA 510(k) clearance (K191532) and fall under product code KRD, classified as Class II devices under special controls. No additional regulatory markings or sterility certifications are specified beyond their FDA authorization.
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: The Caterpillar and Caterpillar Micro Arterial Embolization Devices ..., Bard CTP027015U Caterpillar™ Micro Arterial Embolization Device, K191532 FDA 510(k) - The Caterpillar and Caterpillar Micro A...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191532 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K191532 24 fields · synced Sep 19, 2026