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)

SAFEDWEL(R) CENTRAL VENOUS CATHETER

K-Number: K914528 · 1992-10-13

ApplicantBecton Dickinson Vascular Access, Inc.
Decision Date1992-10-13
Product CodeFOZ
Advisory CommitteeHO
DecisionUnknown

Device Summary

SAFEDWEL(R) CENTRAL VENOUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Vascular Access, Inc.. It received FDA 510(k) clearance on 1992-10-13 under 510(k) number K914528. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SAFEDWEL(R) CENTRAL VENOUS CATHETER?

SAFEDWEL(R) CENTRAL VENOUS CATHETER is a medical device that received FDA 510(k) clearance on 1992-10-13. The listed applicant is Becton Dickinson Vascular Access, Inc.. The 510(k) number is K914528.

When did SAFEDWEL(R) CENTRAL VENOUS CATHETER receive FDA 510(k) clearance?

SAFEDWEL(R) CENTRAL VENOUS CATHETER received FDA 510(k) clearance on 1992-10-13, under 510(k) number K914528.

Who is the listed applicant for SAFEDWEL(R) CENTRAL VENOUS CATHETER?

The FDA 510(k) record lists Becton Dickinson Vascular Access, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFEDWEL(R) CENTRAL VENOUS CATHETER?

The FDA product code for SAFEDWEL(R) CENTRAL VENOUS CATHETER 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 Becton Dickinson Vascular Access, 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.

K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSK970259E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SETK964048FIRST MIDCATH CATHETER KITK964050FIRST MIDCATH CATHETERK964049FIRST MIDCATH CATHETER WITH DUAL LUMENSK954906FIRST PICC INTRODUCER CATHETER

View all 25 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.

↑