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)

VITAL 5 RELEAF CATHETER

K-Number: K122661 · 2013-02-27

ApplicantVital 5
Decision Date2013-02-27
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITAL 5 RELEAF CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vital 5. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K122661. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL 5 RELEAF CATHETER?

VITAL 5 RELEAF CATHETER is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Vital 5. The 510(k) number is K122661.

When did VITAL 5 RELEAF CATHETER receive FDA 510(k) clearance?

VITAL 5 RELEAF CATHETER received FDA 510(k) clearance on 2013-02-27, under 510(k) number K122661.

Who is the listed applicant for VITAL 5 RELEAF CATHETER?

The FDA 510(k) record lists Vital 5 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAL 5 RELEAF CATHETER?

The FDA product code for VITAL 5 RELEAF CATHETER is BSO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: BSO)

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.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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.

↑