FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Merit Pursue Microcatheter
K Number: K173548
·
Decision Mar 30, 2018
Classifications
1
FEI Numbers
271
Registration Numbers
272
Same Product Code
880
Applicant Total
49
Review Days
134
Basic Information
- Device Name
- Merit Pursue Microcatheter
- K Number
- K173548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merit Medical Systems, Inc.
- Date Received
- November 16, 2017
- Decision Date
- March 30, 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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