Concentric Balloon Guide Catheter, Model 90072

• • Terminated Z-0899-2011 FDA Unclassified (pre-2012) ·initiated 27 Feb 2009 ·on shared 510(k) K021899

  Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021899 ↗

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 primary use of the Concentric Balloon Guide Catheter, Model 90072?

  The Concentric Balloon Guide Catheter, Model 90072, is designed for intravascular use to provide temporary vascular occlusion. This helps guide other catheters into peripheral and neurovascular systems during angiographic procedures, ensuring precise device delivery and procedural support within blood vessels.

• Is the Concentric Balloon Guide Catheter, Model 90072, sterile or single-use?

  The catheter is supplied as a single-use device and is non-sterile. It is intended for use in controlled clinical settings where sterility can be maintained through proper handling and preparation before use.

• What size is the Concentric Balloon Guide Catheter, Model 90072, and how is it supplied?

  The catheter is available in a 7 French size, as specified in regulatory filings. It is supplied as a single-use device, meaning each unit is intended for one-time use only to ensure patient safety and procedural integrity.

• How should the Concentric Balloon Guide Catheter, Model 90072, be stored?

  The catheter must be stored in a manner that maintains its integrity before use. Proper storage conditions, such as protecting it from contamination and physical damage, are critical to ensure functionality and safety during procedures.

• What regulatory clearance does the Concentric Balloon Guide Catheter, Model 90072, hold?

  The device holds FDA 510(k) clearance under the reference number K021899. This clearance was granted through a special review process by the FDA’s Cardiovascular Advisory Committee, confirming its substantial equivalence to a predicate device.