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Pressure Products Medical Device Manufacturing, LLC FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)510(k)Mar 13, 2026Cardiovascular
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)510(k)May 17, 2024Cardiovascular
SafeSept® Transseptal Guidewire (SS-140)510(k)Sep 14, 2022Cardiovascular
SafeSept Blunt Needle510(k)Mar 5, 2021Cardiovascular

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