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designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications.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
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11
00643169559981Euphora™EUP22525X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024672554AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672561AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672578AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672585AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672592AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672608AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672615AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672622AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672639AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672646AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672653AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672660AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672677AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672684AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672691AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672707AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672714AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672721AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672738AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672745AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672752AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672769AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672776AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672783AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672790AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672806AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672813AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672820AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672837AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672844AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06