WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / P250015

PMA approved

PerQseal® Elite Vascular Closure Device

Vivasure Medical , Ltd. · Oct 16, 2026 · P250015

FDA approved the PerQseal® Elite Vascular Closure Device from Vivasure Medical , Ltd. on Oct 16, 2026 under P250015, an original premarket approval. The device falls under product code MGB, Device, Hemostasis, Vascular as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 16, 2025. The decision came 487 days later.

This is the only decision on file for Vivasure Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250015?

P250015 is the FDA PMA for PerQseal® Elite Vascular Closure Device, submitted by Vivasure Medical , Ltd.. FDA's decision date was Oct 16, 2026, under product code MGB (Device, Hemostasis, Vascular).

Who makes the PerQseal® Elite Vascular Closure Device?

Vivasure Medical , Ltd., based in Galway, is the applicant of record for P250015.

How long did the P250015 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Oct 16, 2026, 487 days later.

← All decisions in October 2026