FDA.reportPublic FDA data

FlexCath Advance™

Primary DI
00763000418052
Brand
FlexCath Advance™
Company
MEDTRONIC, INC.
Model
4FC12
Device description
SHEATH 4FC12 FLEXCATH ADVANCE 12F US
Published
2020-12-31
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
K202620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202620000FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP2020-11-13DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000418052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000418052007630004180527630004180520763000418052

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length65Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-31 Degrees Fahrenheit136 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

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
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

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