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)

ATTAIN 6215 VENOGRAM BALLOON CATHETER

K-Number: K012225 · 2001-08-28

ApplicantMedtronic Vascular
Decision Date2001-08-28
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTAIN 6215 VENOGRAM BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K012225. 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 ATTAIN 6215 VENOGRAM BALLOON CATHETER?

ATTAIN 6215 VENOGRAM BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Medtronic Vascular. The 510(k) number is K012225.

When did ATTAIN 6215 VENOGRAM BALLOON CATHETER receive FDA 510(k) clearance?

ATTAIN 6215 VENOGRAM BALLOON CATHETER received FDA 510(k) clearance on 2001-08-28, under 510(k) number K012225.

Who is the listed applicant for ATTAIN 6215 VENOGRAM BALLOON CATHETER?

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

What is the FDA product code for ATTAIN 6215 VENOGRAM BALLOON CATHETER?

The FDA product code for ATTAIN 6215 VENOGRAM 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_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 Medtronic Vascular 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.

K232570Steerant™ Super Stiff GuidewireK2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterK2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding CatheterK173515Admiral Xtreme

View all 474 devices →

Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-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 LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-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.

↑