THE CROSSER CATHETER - System Electronics

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

510(k) Number

K062868 ↗

FDA Product Code

DQY

Models / Variants

CR1100

System Electronics

Model FG1002-02

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• The Crosser 14 Otw Catheter, Model CRU014

  Class II

  FDA 510(k) K091254 Active Cleared 29 May 2009

• Microsheath Xl Catheters

  Class II

  FDA 510(k) K073289 Active Cleared 11 Jan 2008

• Vp Wire GW140ST (.014 165cm, Standar), Model GW140ST; Vp Wire GW140SO (.014 165cm, Soft) Model GW140SO

  Class II

  FDA 510(k) K051062 Active Cleared 15 Jul 2005

• The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200

  Class II

  FDA 510(k) K092175 Active Cleared 17 Feb 2010

• Flowcardia Flowmater Injector, Model Inj 100

  Class II

  FDA 510(k) K090621 Active Cleared 19 Jun 2009

• Modification to the Crosser System

  Class II

  FDA 510(k) K091119 Active Cleared 15 May 2009

See all devices from Flowcardia, Inc. →

• What is the Crosser Catheter CR1100 with FG1002-02 Electronics designed for?

  This device is specifically designed for percutaneous cardiovascular procedures to help cross occluded or stenotic vessels. By combining mechanical and electronic components, it improves navigability and precision during catheter placement, aiding in restoring blood flow where blockages or narrowing occur.

• How is the Crosser Catheter CR1100 and FG1002-02 Electronics supplied?

  The system is supplied as a sterile, single-use device. This ensures safety and hygiene for each procedure, preventing cross-contamination and reducing the risk of infection. Each package is intended for one-time use only, as outlined in the manufacturer’s instructions.

• Does this catheter require fluoroscopic imaging for use?

  Yes, the Crosser Catheter CR1100 and FG1002-02 Electronics are designed to be used with fluoroscopic imaging for real-time procedural guidance. This imaging modality helps clinicians visualize the catheter’s position within the vessel, ensuring accurate and safe placement during interventional procedures.

• Where is this device intended for use?

  The device is intended for use in controlled clinical settings, such as cardiac catheterization labs. These environments provide the necessary infrastructure, including fluoroscopy and sterile conditions, to perform interventional procedures safely and effectively.

• What regulatory pathway does the Crosser Catheter follow?

  The Crosser Catheter CR1100 and FG1002-02 Electronics received FDA 510(k) clearance under product code DQY, which falls under the classification of cardiovascular devices (FDA regulation 870.1250). This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device.