FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K Number: K943737
·
Decision Aug 17, 1994
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
432
Review Days
15
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Basic Information
- Device Name
- MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
- K Number
- K943737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- August 2, 1994
- Decision Date
- August 17, 1994
- Product Code
- OCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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