FDA.reportPublic FDA data

Fast-Cath™

Primary DI
05414734202992
Brand
Fast-Cath™
Company
ST. JUDE MEDICAL, INC.
Model
406854
Catalog number
406854
Device description
Guiding Introducer
Published
2015-04-11
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
05414734202992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734202992054147342029925414734202992

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.5French
Length63Centimeter

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 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
05415067053039Current™PFA-AMP-RETURN-CBLPFA-AMP-RETURN-CBL2026-08-03
05415067055002Current™PFA-TSQ-CBLPFA-TSQ-CBL2026-08-03
05415067055583Current™PFA-GEN-OVERLAY-FPFA-GEN-OVERLAY-F2026-08-03
05415067055897Current™PFA-GEN-V110PFA-GEN-V1102026-08-03
00811806011295Amplatzer™9-PFO-0309-PFO-0302026-07-31
05415067045447Epic™EMAX-21EMAX-212023-08-01
05415067045454Epic™EMAX-25EMAX-252023-08-01
05415067045461Epic™EMAX-19EMAX-192023-08-01
05415067045478Epic™EMAX-23EMAX-232023-08-01
05415067033017Epic™E200-21AE200-21A2021-12-09
05415067033024Epic™E200-23AE200-23A2021-12-09
05415067033031Epic™E200-25AE200-25A2021-12-09
05415067033048Epic™E200-25ME200-25M2021-12-09
05415067033055Epic™E200-27AE200-27A2021-12-09
05415067033062Epic™E200-27ME200-27M2021-12-09
05415067033079Epic™E200-29AE200-29A2021-12-09
05415067033086Epic™E200-29ME200-29M2021-12-09
05415067033093Epic™E200-31ME200-31M2021-12-09
05415067033109Epic™E200-33ME200-33M2021-12-09
05415067033116Epic™ESP200-19ESP200-192021-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226416ARROWTELEFLEX INCORPORATEDDYB2026-08-03
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DYB2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19