FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
K Number: K250775
·
Decision May 14, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
17
Review Days
61
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Basic Information
- Device Name
- Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
- K Number
- K250775
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imperative Care, Inc.
- Date Received
- March 14, 2025
- Decision Date
- May 14, 2025
- Product Code
- QEW
- 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 |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
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Other Clearances by Imperative Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252046 | Zoom System (Zoom 4S Catheter) | Oct 30, 2025 | Substantially Equivalent |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Aug 28, 2025 | Substantially Equivalent |
| K244061 | X-Wire Guidewire | Aug 26, 2025 | Substantially Equivalent |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | May 28, 2025 | Substantially Equivalent |
| K242672 | Zoom System | Jan 14, 2025 | Substantially Equivalent |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Jun 6, 2024 | Substantially Equivalent |
| K233975 | Zoom 6F Insert Catheters | Apr 2, 2024 | Substantially Equivalent |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | May 22, 2023 | Substantially Equivalent |
| K220807 | Imperative Care Radial 088 Access System | May 17, 2022 | Substantially Equivalent |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Sep 20, 2021 | Substantially Equivalent |