SafeSept Transseptal Guidewire

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.

Pre-market Notification Details

Device IDK170671
510k NumberK170671
Device Name:SafeSept Transseptal Guidewire
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-06
Decision Date2017-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30858769006105 K170671 000

Trademark Results [SafeSept Transseptal Guidewire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAFESEPT TRANSSEPTAL GUIDEWIRE
SAFESEPT TRANSSEPTAL GUIDEWIRE
77281266 3517730 Live/Registered
PRESSURE PRODUCTS MEDICAL SUPPLIES INC.
2007-09-17
SAFESEPT TRANSSEPTAL GUIDEWIRE
SAFESEPT TRANSSEPTAL GUIDEWIRE
77281253 3547842 Live/Registered
PRESSURE PRODUCTS MEDICAL SUPPLIES INC.
2007-09-17

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