FDA.reportPublic FDA data

PALMAZ MULLINS XD Pulmonary Stent

Primary DI
20705032101186
Brand
PALMAZ MULLINS XD Pulmonary Stent
Company
Cordis US Corp.
Model
PM1910PXD
Catalog number
PM1910PXD
Device description
PALMAZ MULLINS 8F UNEXP L19MM D10-12MM
Published
2025-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWCPulmonary Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWCPulmonary StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220004000PALMAZ MULLINS XD Pulmonary StentCordis US Corp2023-07-21QWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032101186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503210118620705032101186

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal tracheal/bronchial/vascular stentA non-bioabsorbable, tubular device intended to be implanted to indefinitely maintain patency/improve luminal diameter of a blood vessel (peripheral artery and/or vein) and, alternatively, the tracheobronchial tree; it may in addition be intended to be used in the biliary tract. It is not intended for implantation in a coronary or cerebral artery and not intended for shunting. It is a tubular bare-metal mesh implanted with a balloon catheter or delivery device (balloon and/or self-expanding). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100830VISTA BRITE TIP670-040-00M670-040-00M2024-09-09
10705032100892VISTA BRITE TIP778-034-00M778-034-00M2024-09-09
10705032100922VISTA BRITE TIP670-008-00M670-008-00M2024-09-09
10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
10862028000434MYNX CONTROLMX6760MX67602018-10-22
10862028000427MYNX CONTROLMX5060MX50602018-10-22
20705032036440Cordis PRECISE PRO Rx Nitinol Stent SystemPC0720RXCPC0720RXC2014-09-17
10705032009768AVANTI504405X504405X2016-08-01
10705032009775AVANTI504406X504406X2016-08-01
10705032009799AVANTI504408X504408X2016-08-01
10705032009881AVANTI504509X504509X2016-08-01
10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20705032101193PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101209PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101216PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101223PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
00196852801862Minima Stent System - 6mmRENATA MEDICAL, INC.QWC2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.QWC2025-04-02