Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SENDERO Microcatheter

K-Number: K231600 · 2023-11-17

ApplicantOkami Medical, Inc.
Decision Date2023-11-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENDERO Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Okami Medical, Inc.. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K231600. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENDERO Microcatheter?

SENDERO Microcatheter is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Okami Medical, Inc.. The 510(k) number is K231600.

When did SENDERO Microcatheter receive FDA 510(k) clearance?

SENDERO Microcatheter received FDA 510(k) clearance on 2023-11-17, under 510(k) number K231600.

Who is the listed applicant for SENDERO Microcatheter?

The FDA 510(k) record lists Okami Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENDERO Microcatheter?

The FDA product code for SENDERO Microcatheter is DQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07525518Okami Medical ALPHA RegistryENROLLING_BY_INVITATION

Other records listing Okami Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260508LOBO Vascular Occlusion SystemK242644SENDERO MAX Delivery CatheterK240384SENDERO MicrocatheterK220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)K203025LOBO Vascular Occlusion System (model LOBO-5)K192083Okami Medical LOBO Vascular Occlusion System

View all 7 devices →

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑