Concentric Balloon Guide Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K102657 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Trevo Provue Retriever Open recall

  Class II

  FDA 510(k) K133464 Active Cleared 17 Jan 2014

• Modified Concentric Microcatheter Open recall

  Class II

  FDA 510(k) K131437 Active Cleared 11 Oct 2013

• Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113

  Class II

  FDA 510(k) K090085 Active Cleared 12 Feb 2009

• Modified Hd Guide Catheter

  Class II

  FDA 510(k) K110483 Active Cleared 4 Apr 2011

• Modified Concentric Microcatheter, Model 90047

  Class II

  FDA 510(k) K091961 Active Cleared 30 Jul 2009

• Modification to Merci Retriever

  Class II

  FDA 510(k) K082034 Active Cleared 15 Aug 2008

See all devices from Concentric Medical, Inc. →

• What is the Concentric Balloon Guide Catheter used for?

  The Concentric Balloon Guide Catheter is a medical device used primarily in neurovascular procedures to assist in the placement of stents or other devices. It provides vascular access and support during endovascular procedures, facilitating the delivery of therapeutic devices by interventional radiologists and neurosurgeons.

• Is the Concentric Balloon Guide Catheter single-use or reusable?

  The Concentric Balloon Guide Catheter is supplied as a single-use device, meaning it should be used for one patient procedure only and then discarded. This helps ensure patient safety and device performance by preventing cross-contamination and potential device degradation from reuse.

• What regulatory approval has the Concentric Balloon Guide Catheter received?

  The Concentric Balloon Guide Catheter has received FDA 510(k) clearance with the product code DQY. It was reviewed by the Cardiovascular advisory committee and determined to be substantially equivalent to predicate devices, making it available for clinical use in neurovascular and peripheral vascular interventions.

• What are the storage requirements for the Concentric Balloon Guide Catheter?

  The Concentric Balloon Guide Catheter requires appropriate storage conditions to maintain its integrity and functionality. While specific storage details aren't provided in the device data, medical catheters typically need to be stored in a controlled environment, away from extreme temperatures, direct sunlight, and potential contaminants, until ready for use.