XO CROSS CORONARY Support Catheter— 510(k) K214107
Substantially EquivalentTransit Scientific, LLC
FDA 510(k) clearance K214107 for XO CROSS CORONARY Support Catheter, Substantially Equivalent on 2022-04-11. Applicant: Transit Scientific, LLC. Device class: 2.
Clearance details
- Applicant
- Transit Scientific, LLC
- Product code
- Code DQY
- 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
Recent devices under product code DQY
view allMore 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,)
- K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
- K210322 — XO Cross Support Catheter
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.