FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-Wire Guidewire
K Number: K244061
·
Decision Aug 26, 2025
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
17
Review Days
238
Basic Information
- Device Name
- X-Wire Guidewire
- K Number
- K244061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imperative Care, Inc.
- Date Received
- December 31, 2024
- Decision Date
- August 26, 2025
- Product Code
- MOF
- 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 |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
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Other Clearances by Imperative Care, Inc.
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|---|---|---|---|
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| 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 |