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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K253799

510(k) cleared

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

Pressure Products Medical Device Manufacturing, LLC · Mar 13, 2026 · K253799

FDA cleared the SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) from Pressure Products Medical Device Manufacturing, LLC on Mar 13, 2026 under K253799, a special 510(k). The device falls under product code DXF, Catheter, Septostomy, regulated at 21 CFR 870.5175 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 28, 2025. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Pressure Products Medical Device Manufacturing, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253799?

K253799 is the FDA 510(k) for SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R), submitted by Pressure Products Medical Device Manufacturing, LLC. FDA's decision date was Mar 13, 2026, under product code DXF (Catheter, Septostomy).

Who makes the SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)?

Pressure Products Medical Device Manufacturing, LLC, based in Morton, PA, is the applicant of record for K253799.

How long did the K253799 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Mar 13, 2026, 105 days later.

← All decisions in March 2026