FDA.reportPublic FDA data

Paradise® Cartridge

Primary DI
00810008950074
Brand
Paradise® Cartridge
Company
Recor Medical, Inc.
Model
PRDS-CT-02
Catalog number
PRDS-CT-02
Device description
PRDS-CT-02 Paradise® Cartridge
Published
2023-12-11
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
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
10810008950071PackageGS15In Commercial Distribution
00810008950074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000895007110810008950071
00810008950074008100089500748100089500740810008950074

GMDN Terms#

Term, Definition table
TermDefinition
Renal denervation ultrasound system cooling solution flow chamberA component of an ultrasound renal denervation system designed to facilitate system generator-controlled flow of cooling solution (e.g., sterile water) to the system catheter during renal denervation (RDN). It includes tubing, electronic sensors and syringes, and is intended to receive power from, and send signals to, the generator. The flow of cooling fluid to the catheter tip is intended to prevent arterial wall damage during ultrasound denervation. This is a single-use device.

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
00810008950043Paradise® CatheterPRDS-068-02PRDS-068-022023-12-11
00810008950067Paradise® CatheterPRDS-063-02PRDS-063-022023-12-11
00810008950104Paradise® CartPRDS-CRTPRDS-CRT2024-01-10
00810008950050Paradise® Connection CablePRDS-CC-02PRDS-CC-022023-12-11
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
00810008950043Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950050Paradise® Connection CableRecor Medical, Inc.QYI2023-12-11
00810008950067Paradise® CatheterRecor 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