MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE— 510(k) K943737
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K943737 for MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE, Substantially Equivalent on 1994-08-17. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code OCY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watertown, MA, US
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More clearances from Boston Scientific Corp
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- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code OCY
product code OCY- Injury
- 186
- Malfunction
- 578
- Total
- 764
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.