Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BOBBY Balloon Guide Catheter

K-Number: K193607 · 2020-07-21

ApplicantMicroVention, Inc.
Decision Date2020-07-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOBBY Balloon Guide Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2020-07-21 under approval number K193607. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOBBY Balloon Guide Catheter?

BOBBY Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-07-21. It is manufactured by MicroVention, Inc.. The 510(k) number is K193607.

When was BOBBY Balloon Guide Catheter approved by the FDA?

BOBBY Balloon Guide Catheter received FDA 510(k) clearance on 2020-07-21, under approval number K193607.

What company makes BOBBY Balloon Guide Catheter?

BOBBY Balloon Guide Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for BOBBY Balloon Guide Catheter?

The FDA product code for BOBBY Balloon Guide Catheter is DQY.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

View all 28 devices →

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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.

↑