FDA.reportPublic FDA data

STRADIS

Primary DI
M752SS202201
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
SS20220
Device description
INTRODUCER KIT
Published
2016-09-01
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
K043525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043525000CATHETER INTRODUCERGalt Medical Corp.2005-02-09DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752SS202201PrimaryHIBCC0

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designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications.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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31
M7521697700Stradis Medical, LLC.1697702018-03-22
M752ACC25001Stradis Medical, LLC.ACC-25002018-01-29
M752ACC2500N1Stradis Medical, LLC.ACC-2500N2018-04-13
M752ACC25501Stradis Medical, LLC.ACC-25502018-01-29
M752DC1790911Stradis Medical, LLC.DC-17909-12018-05-22
M752DC51601Stradis Medical, LLC.DC-51602018-05-22
M752HCT6625TC0Stradis Medical, LLC.HCT6625TC2017-12-12
M752IM12350Stradis Medical, LLC.IM12352017-12-15
M752IM12510Stradis Medical, LLC.IM12512017-12-15
M752IM12600Stradis Medical, LLC.IM12602019-04-17
M752IMSEN101A0Stradis Medical, LLC.IM-SEN-101A2017-12-14
M752MAG30001Stradis Medical, LLC.MAG-30002018-05-30
M752ACC2550N1Stradis Medical, LLC.ACC-2550N2018-03-27
M752DC850A0Stradis Medical, LLC.DC-850A2018-04-23
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07