FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MitraClip G4 Steerable Guide Catheter
K Number: K221397
·
Decision Sep 28, 2022
Classifications
1
FEI Numbers
41
Registration Numbers
42
Same Product Code
40
Applicant Total
44
Review Days
138
Basic Information
- Device Name
- MitraClip G4 Steerable Guide Catheter
- K Number
- K221397
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Medical
- Date Received
- May 13, 2022
- Decision Date
- September 28, 2022
- Product Code
- DRA
- 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
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