FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EmeryGlide (EG18008901)
K Number: K253262
·
Decision Mar 6, 2026
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
3
Review Days
158
Basic Information
- Device Name
- EmeryGlide (EG18008901)
- K Number
- K253262
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nano4imaging GmbH
- Date Received
- September 29, 2025
- Decision Date
- March 6, 2026
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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