The Crosser System

• • Terminated Z-0938-2011 FDA Unclassified (pre-2012) ·initiated 9 Jan 2009 ·on shared 510(k) K072776

  Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.

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

510(k) Number

K072776 ↗

FDA Product Code

PDU

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

• Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02

  Class II

  FDA 510(k) K062868 Active Cleared 19 Jan 2007

• 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

See all devices from Flowcardia, Inc. →