FDA.reportPublic FDA data

Symplicity Spyral™

Primary DI
00763000354466
Brand
Symplicity Spyral™
Company
MEDTRONIC, INC.
Model
RDN016
Device description
SPYRAL CATHETER RDN016 US COMMERCIAL
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYIAblation catheter, renal denervation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYIAblation Catheter, Renal DenervationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220026000Symplicity Spyral™ Renal Denervation SystemMedtronic, Inc.2023-11-17QYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000354466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000354466007630003544667630003544660763000354466

GMDN Terms#

Term, Definition table
TermDefinition
Renal denervation radio-frequency ablation catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
Storage Environment Atmospheric Pressure30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure595 millibar1060 millibar
Storage Environment Temperature-35 Degrees Celsius57 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810008950005Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950012Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950029Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950036Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950043Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950050Paradise® Connection CableRecor Medical, Inc.QYI2023-12-11
00810008950067Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950074Paradise® CartridgeRecor Medical, Inc.QYI2023-12-11
00810008950098Paradise® RemoteRecor Medical, Inc.QYI2023-12-11
00810008950111Paradise® GeneratorRecor Medical, Inc.QYI2023-12-11
00810008950128Paradise® GeneratorRecor Medical, Inc.QYI2023-12-11
00763000387020Symplicity G3™MEDTRONIC, INC.QYI2023-11-30