FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GORE Tri-Lumen Catheter
K Number: K180919
·
Decision Oct 5, 2018
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
3
Review Days
179
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Basic Information
- Device Name
- GORE Tri-Lumen Catheter
- K Number
- K180919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W. L. Gore and Associates, Inc.
- Date Received
- April 9, 2018
- Decision Date
- October 5, 2018
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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