FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Tigertriever 13 Revascularization Device
K Number: K220808
·
Decision Jul 25, 2022
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
6
Review Days
129
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Basic Information
- Device Name
- Tigertriever 13 Revascularization Device
- K Number
- K220808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rapid Medical , Ltd.
- Date Received
- March 18, 2022
- Decision Date
- July 25, 2022
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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Other Clearances by Rapid Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253062 | Tigertriever 25 Revascularization Device | Mar 12, 2026 | Substantially Equivalent |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Oct 6, 2025 | Substantially Equivalent |
| DEN230064 | BraidE Embolization Assist Device | Feb 21, 2024 | Unknown |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | Apr 17, 2023 | Substantially Equivalent |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Mar 23, 2021 | Substantially Equivalent |