Bendit2.7 Steerable Microcatheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200582 FDA 510(k)
- FDA Product Code
- KRA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1210 FDA 510(k)
- Regulation Number
- 870.1210 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bendit2.7 Steerable Microcatheter is a catheter, continuous flush, classified as a Class II medical device under FDA regulation 870.1210. It is designed for use in cardiovascular procedures, as indicated by its device type and advisory committee classification.
The device is supplied as a single-use, sterile product intended for use in clinical settings. It has received FDA 510(k) clearance (K200582) and is manufactured by Bend IT Technologies, Ltd. No information regarding MRI safety, specific sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the Bendit2.7 Steerable Microcatheter used for?
The Bendit2.7 Steerable Microcatheter is designed for use in cardiovascular procedures, as indicated by its device type and advisory committee classification under FDA regulation 870.1210.
Is the Bendit2.7 Steerable Microcatheter sterile and single-use?
Yes, the device is supplied as a single-use, sterile product intended for use in clinical settings, ensuring it is ready for immediate use without reprocessing.
What regulatory clearance does the Bendit2.7 Steerable Microcatheter have?
The Bendit2.7 Steerable Microcatheter has received FDA 510(k) clearance under submission number K200582, confirming its substantial equivalence to a legally marketed predicate device.
Who manufactures the Bendit2.7 Steerable Microcatheter?
The Bendit2.7 Steerable Microcatheter is manufactured by Bend IT Technologies, Ltd., located at 25 Basel St., Petach Tikva, Israel, as specified in the device authorization data.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200582 | Class II | Active |
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Manufacturer
- Manufacturer
- Bend IT Technologies, Ltd.
Sources (1)
- FDA 510(k) K200582 24 fields · synced Sep 21, 2026