FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
K Number: K212224
·
Decision Sep 20, 2021
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
17
Review Days
66
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Basic Information
- Device Name
- TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
- K Number
- K212224
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imperative Care, Inc.
- Date Received
- July 16, 2021
- Decision Date
- September 20, 2021
- Product Code
- QJP
- 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 |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | 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 |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | May 14, 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 |