Home / 510(k) Clearances / K193607

510(k) K193607

BOBBY Balloon Guide Catheter by MicroVention, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2020
Date Received
December 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by MicroVention, Inc.

  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K232542 — Wedge XL Delivery Catheter (May 16, 2024)
  • K230775 — SOFIA EX Intracranial Support Catheter (September 14, 2023)
  • K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (April 27, 2023)
  • K222115 — ISAAC Neurovascular Navigation Catheter (January 10, 2023)
  • K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880 (December 21, 2022)
  • K214024 — SOFIA 88 Catheter (September 12, 2022)
  • K211120 — ERIC Retrieval Device (March 31, 2022)
  • K201487 — Traxcess 7 Mini Guidewire (July 2, 2020)
  • K200547 — Traxcess 14 SELECT Guidewire (April 16, 2020)

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)