XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter— 510(k) K232258

Clearance details

Applicant

Transit Scientific, LLC

Product code

Code PNO

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2023-07-31

Decision date

2024-06-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

• K260012 — UltraScore Focused Force PTA Balloon2026-02-04
• K243944 — Aperta NSE PTA Balloon Dilatation Catheter2025-04-22
• K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter2025-04-21
• K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter2024-10-22
• K232013 — Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)2024-03-28

• K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)2023-11-29
• K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter2022-10-18
• K214107 — XO CROSS CORONARY Support Catheter2022-04-11
• K210322 — XO Cross Support Catheter2021-10-21

Malfunction

1,646

Total

1,646

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →