510(k) K253262
K253262 is an FDA 510(k) premarket notification submitted by Nano4imaging GmbH for the device "EmeryGlide (EG18008901)". The FDA issued a decision of Substantially Equivalent on March 6, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Nano4imaging GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2026
- Date Received
- September 29, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type