XO Score Percutaneous Transluminal Angioplasty Scoring Catheter— 510(k) K193495
Substantially EquivalentTransit Scientific
FDA 510(k) clearance K193495 for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter, Substantially Equivalent on 2020-05-29. Applicant: Transit Scientific. Device class: 2.
Clearance details
- Applicant
- Transit Scientific
- Product code
- 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
Recent devices under product code PNO
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- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
More clearances from Transit Scientific
view allAdverse 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.