XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter— 510(k) K232258
Substantially EquivalentTransit Scientific, LLC
FDA 510(k) clearance K232258 for XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter, Substantially Equivalent on 2024-06-17. 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
- Traditional
- Location
- Salt Lake City, UT, US
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More clearances from Transit Scientific, LLC
view all- 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,)
- K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
- 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.