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
- Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
- 95.00
- 30.00
- 1060.00
- 595.00
- 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
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 IdentifiersDevice 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