FDA.reportPublic FDA data

Fast-Cath™

Primary DI
05414734217293
Brand
Fast-Cath™
Company
ST. JUDE MEDICAL, INC.
Model
406975
Catalog number
406975
Device description
Guiding Introducer
Published
2015-03-06
Public version status
Update
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061015000FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCERSt Jude Medical2006-08-03DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734217293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734217293054147342172935414734217293

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular device introducer, non-steerableA sterile tubular sheath designed for percutaneous placement in the cardiovascular system and through which other cardiovascular devices (e.g., cardiac/intravascular catheter, pacing lead) are subsequently inserted for positioning in blood vessels and/or chambers of the heart. The non-steerable distal tip is typically curved to accommodate manoeuvring in the cardiac anatomy. It may be fitted with a haemostasis valve (HV) to minimize blood loss during the intervention [e.g., electrophysiology (EP)], have a sideport for aspiration/infusion/blood sampling, have radiopaque graduated markings making it x-ray visible, and may include a dedicated intraluminal dilator. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.5French
Length60Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
Special Storage Condition, Specify00STORE IN A COOL, DARK, DRY PLACE AWAY FROM RADIATION.
Special Storage Condition, Specify00STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067057952EnSite™ENSITE-D-AG-01ENSITE-D-AG-012026-09-21
05415067057969EnSite™ENSITE-AG-01ENSITE-AG-012026-09-21
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12

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