Symplicity Spyral™

GUDID 00763000354466

SPYRAL CATHETER RDN016 US COMMERCIAL

MEDTRONIC, INC.

Renal denervation radio-frequency ablation catheter
Primary Device ID00763000354466
NIH Device Record Key002038bf-d386-4268-85de-9e6ce3a12fb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymplicity Spyral™
Version Model NumberRDN016
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar
Storage Environment TemperatureBetween -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric PressureBetween 595 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000354466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QYIAblation catheter, renal denervation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-08
Device Publish Date2023-11-30

Devices Manufactured by MEDTRONIC, INC.

00199150021055 - NA2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
00199150021062 - NA2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
00199150021079 - NA2025-06-06 CUSTOM PACK BB7C59R10 E C L S
20199150021110 - NA2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
20199150021134 - NA2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE

Trademark Results [Symplicity Spyral]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYMPLICITY SPYRAL
SYMPLICITY SPYRAL
97652566 not registered Live/Pending
Medtronic Ireland Manufacturing Unlimited Company
2022-10-28
SYMPLICITY SPYRAL
SYMPLICITY SPYRAL
97119448 not registered Live/Pending
Medtronic, Inc.
2021-11-11
SYMPLICITY SPYRAL
SYMPLICITY SPYRAL
87541444 not registered Live/Pending
Medtronic Ardian Luxembourg S.a.r.l.
2017-07-25
SYMPLICITY SPYRAL
SYMPLICITY SPYRAL
85928930 not registered Dead/Abandoned
Medtronic Ardian Luxembourg S.a.r.l.
2013-05-10
SYMPLICITY SPYRAL
SYMPLICITY SPYRAL
85797529 5022773 Live/Registered
Medtronic Ardian Luxembourg S.a.r.l.
2012-12-07

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.