FDA.reportPublic FDA data

Paradise® Catheter

Primary DI
00810008950043
Brand
Paradise® Catheter
Company
Recor Medical, Inc.
Model
PRDS-068-02
Catalog number
PRDS-068-02
Device description
PRDS-068-02 Paradise® Catheter 8mm
Published
2023-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P220023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220023000Paradise® Ultrasound Renal Denervation SystemRecor Medical, Inc.2023-11-07QYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008950043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008950043008100089500438100089500430810008950043

GMDN Terms#

Term, Definition table
TermDefinition
Renal denervation ultrasound system catheterAn electrically-powered, steerable, thin, flexible tube intended to be introduced percutaneously into the renal artery to emit ultrasound energy, with simultaneous arterial wall cooling to prevent arterial wall damage, for renal denervation (RDN). It includes a distal ultrasound transducer and balloon for the circulation of cooling fluids. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16505427700regulatoryaffairs@recormedical.com

Regulatory Flags#

DUNS number
943549670
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008950005Paradise® CatheterPRDS-064-02PRDS-064-022023-12-11
00810008950012Paradise® Catheter PRDS-065-02PRDS-065-022023-12-11
00810008950029Paradise® Catheter PRDS-066-02PRDS-066-022023-12-11
00810008950036Paradise® CatheterPRDS-067-02PRDS-067-022023-12-11
00810008950067Paradise® CatheterPRDS-063-02PRDS-063-022023-12-11
00810008950104Paradise® CartPRDS-CRTPRDS-CRT2024-01-10
00810008950050Paradise® Connection CablePRDS-CC-02PRDS-CC-022023-12-11
00810008950074Paradise® CartridgePRDS-CT-02PRDS-CT-022023-12-11
00810008950098Paradise® RemotePRDS-RMPRDS-RM2023-12-11
00810008950111Paradise® GeneratorPRDS-USG-2XPRDS-USG-2X2023-12-11
00810008950128Paradise® GeneratorPRDS-USG-2XPRDS-USG-2X2023-12-11

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
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
00763000354466Symplicity Spyral™MEDTRONIC, INC.QYI2023-11-30
00763000387020Symplicity G3™MEDTRONIC, INC.QYI2023-11-30