K232258 - XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (FDA 510(k) Clearance)

K232258 is an FDA 510(k) clearance for the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Transit Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 17, 2024 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Transit Scientific, LLC devices