Cleared Traditional

BOBBY Balloon Guide Catheter

K193607 · MicroVention, Inc. · Neurology
Jul 2020
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K193607 is an FDA 510(k) clearance for the BOBBY Balloon Guide Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on July 21, 2020, 208 days after receiving the submission on December 26, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K193607 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2019
Decision Date July 21, 2020
Days to Decision 208 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

Similar Devices — DQY Catheter, Percutaneous

All 885
Amplatzer? Trevisio? Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo? Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025
CPS Locator 3D Delivery Catheter
K250147 · Centerpoint Systems · Aug 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · Reflow Medical, Inc. · Aug 2025