ClearanceBrief
Panels › Cardiovascular › Product code DQX · Class 2

Wire, Guide, Catheter

Regulation 870.1330

12510(k)s in 12 months (769 all time)
7recalls in 12 months (258 all time)
224recalls that name a 510(k)
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Top companies in DQX

Company510(k)sRecalls
Cook Incorporated2661
Boston Scientific3442
Argon Medical Devices, Inc.153
Asahi Intecc Co., Ltd.480
Advanced Cardiovascular Systems, Inc.450
Arrow International, Inc.131
Lake Region Mfg., Inc.310
Merit Medical Systems, Inc.229
Scimed Life Systems, Inc.300
Guidant Corp.270
DateFirm and productCodeLinked 510(k)
Jul 12, 2006Boston Scientific
Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 U
Terminated		 DQXNone listed
Jul 12, 2006Boston Scientific
Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Co
Terminated		 DQXK040140
Oct 30, 2003Boston Scientific
PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305
Terminated		 DQXK032050
Mar 20, 2003Symbiosis Corp.
Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
Terminated		 DQXK933334
Feb 27, 2003Symbiosis Corp.
Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) proce
Terminated		 DQXK962572
Feb 27, 2003Symbiosis Corp.
Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
Terminated		 DQXK962572
Feb 27, 2003Symbiosis Corp.
Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
Terminated		 DQXK960657
Feb 27, 2003Symbiosis Corp.
Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is s
Terminated		 DQXK962572

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