FDA.reportPublic FDA data

Transseptal Introducer

Primary DI
30858769006327
Brand
Transseptal Introducer
Company
PPMDM
Model
TSIL18563
Catalog number
TSIL18563
Device description
8.5F x 63cm Transseptal Introducer Set L1 Curve
Published
2018-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181031000TSI Transseptal IntroducerPressure Products Medical Device Manufacturing, LLC2018-10-26DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30858769006327PackageGS15In Commercial Distribution
00858769006326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085876900632730858769006327
00858769006326008587690063268587690063260858769006326

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081047841
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858769006487SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006500SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006524SafeSept RF Transseptal GuidewireSSRF1352026-03-23
00858769006531SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
00858769006548SafeSept RF Transseptal GuidewireSSRF2352026-03-23
00858769006555SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
30858769006488SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006494SafeSept RF Transseptal GuidewireSSRF132RSSRF132R2026-03-23
30858769006501SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006517SafeSept RF Transseptal GuidewireSSRF232R2026-03-23
30858769006525SafeSept RF Transseptal GuidewireSSRF1352026-03-23
30858769006532SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
30858769006549SafeSept RF Transseptal GuidewireSSRF2352026-03-23
30858769006556SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
00858769006425SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
00858769006449SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02
00858769006456SafeSharp Transseptal NeedleCLICK171CLICK1712024-07-02
00858769006470SafeSharp Transseptal NeedleCLICK198CLICK1982024-07-02
30858769006426SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
30858769006440SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02

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Primary DI, Brand, Company table
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