FDA.reportPublic FDA data

SELUTION SLR™ 014 PTCA Drug-Eluting Balloon

Primary DI
00810220870396
Brand
SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
Company
Medalliance, LLC
Model
SCB14U-350030D
Device description
SEL 3.50x30 014 RX 140 US
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250041000SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedAlliance, LLC2026-09-18OOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810220870396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810220870396008102208703968102208703960810220870396

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, drug-coatedA flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously release a drug intended to inhibit restenosis. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. It may be available as an over-the-wire (OTW) or a rapid exchange (RX) type, and devices to assist catheterization may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter0
Balloon Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store near radiation or ultraviolet sources
Special Storage Condition, Specify00Store in a dry, dark, and cool place
Special Storage Condition, Specify00Store in Original Packaging
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
800-327-7714brandon.casadecalvo@cordis.com

Regulatory Flags#

DUNS number
022888327
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810220870068SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-225015D2026-09-21
00810220870075SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-225020D2026-09-21
00810220870082SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-225025D2026-09-21
00810220870099SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-225030D2026-09-21
00810220870129SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-250015D2026-09-21
00810220870136SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-250020D2026-09-21
00810220870143SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-250025D2026-09-21
00810220870150SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-250030D2026-09-21
00810220870181SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-275015D2026-09-21
00810220870198SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-275020D2026-09-21
00810220870204SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-275025D2026-09-21
00810220870211SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-275030D2026-09-21
00810220870242SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-300015D2026-09-21
00810220870259SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-300020D2026-09-21
00810220870266SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-300025D2026-09-21
00810220870273SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-300030D2026-09-21
00810220870303SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-325015D2026-09-21
00810220870310SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-325020D2026-09-21
00810220870327SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-325025D2026-09-21
00810220870334SELUTION SLR™ 014 PTCA Drug-Eluting BalloonSCB14U-325030D2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220870068SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870075SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870082SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870099SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870129SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870136SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870143SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870150SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870181SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870198SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870204SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870211SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870242SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870259SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870266SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870273SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870303SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870310SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870327SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870334SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870365SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870372SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870389SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870426SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870433SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870440SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870457SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870488SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870495SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870501SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21