FDA 510(k)

BARD-PARKER OCCLUSION BALLOON CATHETER

K-Number: K852294 · 1985-09-17

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1985-09-17

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BARD-PARKER OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1985-09-17 under 510(k) number K852294. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD-PARKER OCCLUSION BALLOON CATHETER?

BARD-PARKER OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1985-09-17. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K852294.

When did BARD-PARKER OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

BARD-PARKER OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 1985-09-17, under 510(k) number K852294.

Who is the listed applicant for BARD-PARKER OCCLUSION BALLOON CATHETER?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD-PARKER OCCLUSION BALLOON CATHETER?

The FDA product code for BARD-PARKER OCCLUSION BALLOON CATHETER is DYG.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

K003062BACTEC MGIT 960 SIR KITS K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 K001364BD DIRECTIGEN FLU A+B K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: DYG)

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards Lifesciences K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards Lifesciences K233824Swan-Ganz catheterEdwards Lifesciences, LLC K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC K193466Swan-Ganz CathetersEdwards Lifesciences, LLC

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.