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510(k) Data Aggregation

K Number

K180959

Device Name

Phenom 27 Catheter

Manufacturer

Cathera, Inc.

Date Cleared

2018-06-11

(60 days)

Product Code

DQY, KRA, PER

Regulation Number

870.1250

Intended Use

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Device Description

The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

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K Number

K151638

Device Name

Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter

Manufacturer

Cathera, Inc.

Date Cleared

2015-11-13

(149 days)

Product Code

DQY, CON, KRA

Regulation Number

870.1250

Intended Use

The Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Device Description

The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

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