- Physicians Office Resource

SPYRAL CATHETER RDN016 US COMMERCIAL
Symplicity Spyral™ - RDN016

Device Description

A sterile, steerable, thin, flexible tube containing one or more monopolar electrodes intended to be introduced percutaneously into the renal artery to transmit precisely-focused, low-level, radio-frequency (RF) current, from a connected RF generator, to disrupt renal nerves for therapeutic denervation of the kidney; commonly known as renal denervation (RDN). The device has embedded metallic electrodes and may be available in a variety of forms (e.g., deflectable tip, balloon catheter). This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.

Storage Environment Atmospheric Pressure - Percent (%) Relative Humidity

95.00
30.00

Storage Environment Atmospheric Pressure - millibar

1060.00
595.00

Storage Environment Temperature - Degrees Celsius

57.00
-35.00

Device Sizes

1.78 MM Minimum Inner Diameter

1.32 MM Outer Diameter

117 CM Effective Length

19 MM Tip Diameter

6 FR Guide Catheter

0.36 MM Maximum Guidewire Diameter

1.78 MM Minimum Inner Diameter
1.32 MM Outer Diameter
117 CM Effective Length
19 MM Tip Diameter
6 FR Guide Catheter
0.36 MM Maximum Guidewire Diameter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QYI

Device Name: Ablation Catheter, Renal Denervation

Device Class: 3

Physical State: Catheter and generator

Definition: For denervating the renal nerves to lower blood pressure

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Catheter delivered near the renal nerves to deliver energy to cause denervation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Renal vasculature and nerves

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00763000354466

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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