FDA.reportPublic FDA data

SafeSept RF Transseptal Guidewire

Primary DI
30858769006556
Brand
SafeSept RF Transseptal Guidewire
Company
PPMDM
Model
SSRF235R
Device description
0.035" x 230cm x Retention Transseptal Wires in Five Unit Box
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXFCatheter, Septostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253799000SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC2026-03-13DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30858769006556PackageGS15In Commercial Distribution
00858769006555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085876900655630858769006556
00858769006555008587690065558587690065550858769006555

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal needle, single-useA device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. 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
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
30858769006457SafeSharp Transseptal NeedleCLICK171CLICK1712024-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858769006487SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006500SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006524SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006531SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006548SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006555SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006488SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006494SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006501SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006517SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006525SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006532SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006549SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
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