SafeSept Transseptal Guidewire
K-Number: K170671 · 2017-10-20
Decision Date2017-10-20
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SafeSept Transseptal Guidewire is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2017-10-20 under approval number K170671. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SafeSept Transseptal Guidewire?
SafeSept Transseptal Guidewire is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K170671.
When was SafeSept Transseptal Guidewire approved by the FDA?
SafeSept Transseptal Guidewire received FDA 510(k) clearance on 2017-10-20, under approval number K170671.
What company makes SafeSept Transseptal Guidewire?
SafeSept Transseptal Guidewire is manufactured by Pressure Products Medical Device Manufacturing, LLC.
What is the FDA product code for SafeSept Transseptal Guidewire?
The FDA product code for SafeSept Transseptal Guidewire is DRC.
Related Clinical Trials
Other Devices by Pressure Products Medical Device Manufacturing, LLC
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.