FDA.reportPublic FDA data

FlexCath Contour™

Primary DI
00763000659097
Brand
FlexCath Contour™
Company
MEDTRONIC, INC.
Model
10FCC20
Device description
SHEATH 10FCC20 FLEXCATH CONTOUR 10F US
Published
2024-02-04
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
DRACATHETER, STEERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232321000FlexCath Contour™ Steerable SheathMedtronic, Inc.2023-10-31DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000659097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000659097007630006590977630006590970763000659097

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length65.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

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
00199309001242Percept™ PC BrainSense™B352002026-08-07
00199309001259Percept™ RCB353002026-08-07
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671991AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024672004AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024670314AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670536AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670543AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670550AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024671342AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671359AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671366AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671373AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671380AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671397AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671403AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671410AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671427AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671434AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671441AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671571AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671588AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671595AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671601AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671618AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671625AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671632AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671649AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671687AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671694AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671700AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671731AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671748AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05