XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter— 510(k) K221986
Substantially EquivalentTransit Scientific, LLC
FDA 510(k) clearance K221986 for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter, Substantially Equivalent on 2022-10-18. Applicant: Transit Scientific, LLC. Device class: 2.
Clearance details
- Applicant
- Transit Scientific, LLC
- Product code
- Product code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code PNO
view all- K260686 — Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
- K261778 — JADE SCORE PTA Scoring Balloon Dilatation Catheter
- K260012 — UltraScore Focused Force PTA Balloon
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
More clearances from Transit Scientific, LLC
view all- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- 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,)
- K214107 — XO CROSS CORONARY Support Catheter
- K210322 — XO Cross Support Catheter
Adverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.