SafeSept® Transseptal Guidewire (SS-140)

Trocar

Pressure Products Medical Device Manufacturing LLC.

The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc. with the FDA for Safesept® Transseptal Guidewire (ss-140).

Pre-market Notification Details

Device IDK221707
510k NumberK221707
Device Name:SafeSept® Transseptal Guidewire (SS-140)
ClassificationTrocar
Applicant Pressure Products Medical Device Manufacturing LLC. 1 School Street Morton,  PA  19070
ContactAndrew Armour
CorrespondentAndrew Armour
Pressure Products Medical Device Manufacturing LLC. 1 School Street Morton,  PA  19070
Product CodeDRC  
CFR Regulation Number870.1390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-13
Decision Date2022-09-14

Trademark Results [SafeSept]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAFESEPT
SAFESEPT
87249371 5232606 Live/Registered
Pressure Products Medical Supplies Inc.
2016-11-28

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