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)

STREAMLINE VASCULAR ACCESS DEVICE

K-Number: K896774 · 1989-12-27

ApplicantMenlo Care, Inc.
Decision Date1989-12-27
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STREAMLINE VASCULAR ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Menlo Care, Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896774. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREAMLINE VASCULAR ACCESS DEVICE?

STREAMLINE VASCULAR ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Menlo Care, Inc.. The 510(k) number is K896774.

When did STREAMLINE VASCULAR ACCESS DEVICE receive FDA 510(k) clearance?

STREAMLINE VASCULAR ACCESS DEVICE received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896774.

Who is the listed applicant for STREAMLINE VASCULAR ACCESS DEVICE?

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

What is the FDA product code for STREAMLINE VASCULAR ACCESS DEVICE?

The FDA product code for STREAMLINE VASCULAR ACCESS DEVICE is FOZ.

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

Other records listing Menlo Care, 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.

K964447PICC CATHETER/MIDLINE CATHETERK951620MIDMARK MIDLINE CATHETERK945521CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAYK950737LANDMARK MIDLINE CATHETERK944968LANDMARK MIDLINE CATHETERK943893PERCUTANEOUS GRAINAGE CATHETER

View all 31 devices →

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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.

↑