FDA.reportPublic FDA data

Maximum™

Primary DI
05414734010993
Brand
Maximum™
Company
ST. JUDE MEDICAL, INC.
Model
406690
Catalog number
406690
Device description
HEMOSTASIS 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
K870374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870374000PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCKDaig Corp.1987-03-18DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734010990PackageGS110In Commercial Distribution
05414734010993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473401099015414734010990
05414734010993054147340109935414734010993

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 Gauge9French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DARK, DRY PLACE.

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
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
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03
05415067041517CPS AIM™DS2N100-59DS2N100-592022-10-20
05415067041524CPS Aim™DS2N100-65DS2N100-652022-10-20
05415067041586CPS AIM™DS2N104-65DS2N104-652022-10-20
05415067041739CPS AIM™DS2N101-65DS2N101-652022-10-20
05415067041746CPS AIM™DS2N103-65DS2N103-652022-10-20
05415067041753CPS AIM™DS2N102-65DS2N102-652022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005452TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005469TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005476TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00685447005605SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005612SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005629SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005643SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10