Product code HCA— Neurology

FDA has cleared 10 devices under product code HCA between 1984 and 2017, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20131 clearance
• 20031 clearance
• 20023 clearances
• 20011 clearance
• 19991 clearance
• 19981 clearance
• 19841 clearance

• Codman & Shurtleff, Inc.3 clearances
• Parker Hannifin Corp.1 clearance
• Mri Interventions, Inc.1 clearance
• Medtronic PS Medical1 clearance
• Innerspace, Inc.1 clearance
• Image-Guided Neurologics, Inc.1 clearance
• Bresagen, Inc.1 clearance
• Aesculap, Inc.1 clearance

• K161731 — Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.·2017-03-27
• K123605 — SMARTFLOW CATHETERMri Interventions, Inc.·2013-08-16
• K031123 — CODMAN BACTISEAL BARIUM STRIPED CATHETERSCodman & Shurtleff, Inc.·2003-05-14
• K021481 — BRESAGEN CATHETER, MODEL CS-3000Bresagen, Inc.·2002-08-06
• K020728 — MIETHKE SHUNT SYSTEMAesculap, Inc.·2002-04-05
• K013005 — ACT 11 MP VENTRICULAR CATHETERInnerspace, Inc.·2002-03-08
• K003322 — CODMAN BACTISEAL CATHETERSCodman & Shurtleff, Inc.·2001-10-01
• K992796 — ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000Image-Guided Neurologics, Inc.·1999-10-25
• K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102Medtronic PS Medical·1998-12-16
• K834477 — DISPOS. SCOTT CANNULAS 16-1054 ETC.Codman & Shurtleff, Inc.·1984-03-19