FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Talon Transseptal Sheath
K Number: K231108
·
Decision Sep 27, 2023
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
30
Review Days
161
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Basic Information
- Device Name
- Talon Transseptal Sheath
- K Number
- K231108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inari Medical, Inc.
- Date Received
- April 19, 2023
- Decision Date
- September 27, 2023
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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| K234034 | VenaCore Thrombectomy Catheter (46-101) | Feb 9, 2024 | Substantially Equivalent |
| K233815 | ClotTriever Sheath | Dec 18, 2023 | Substantially Equivalent |
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