Identifiers
- 510(k) Number
- K231600 FDA 510(k)
- FDA Product Code
- DQY 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 SENDERO Microcatheter is a percutaneous catheter designed for use in the peripheral vasculature. It is intended for the infusion of diagnostic and therapeutic agents.
The device is supplied sterile and is for single-use only. It is restricted to sale by or on the order of a physician (Rx Only) and has received FDA 510(k) clearance under K231600.
Frequently asked questions
What is the SENDERO Microcatheter used for?
The SENDERO Microcatheter is designed for percutaneous use in the peripheral vasculature to infuse diagnostic and therapeutic agents, as stated in its intended use description.
Is the SENDERO Microcatheter sterile and for single-use only?
Yes, the device is supplied sterile and is explicitly labeled for single-use only, meaning it should not be reprocessed or reused after initial patient contact.
How is the SENDERO Microcatheter supplied and who can order it?
The SENDERO Microcatheter is supplied sterile and is restricted to sale by or on the order of a physician (Rx Only), requiring a prescription for clinical use.
What regulatory pathway was used for the SENDERO Microcatheter?
The device received FDA 510(k) clearance under submission number K231600, indicating it was found substantially equivalent to a legally marketed predicate device.
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: Sendero - Okami Medical, PDF November 17, 2023 Okami Medical, Inc. Jill Delsman Official ..., PDF Okami Medical, Inc. Jill Delsman Official Applicant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231600 | Class II | Active |
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Manufacturer
- Manufacturer
- Okami Medical, Inc.
Sources (1)
- FDA 510(k) K231600 24 fields · synced Sep 26, 2026