NHanceIT— 510(k) K260559
Substantially EquivalentIMDS Operation B.V.
FDA 510(k) clearance K260559 for NHanceIT, Substantially Equivalent on 2026-08-14. Applicant: IMDS Operation B.V.. Device class: 2.
Summary
IMDS Operation's NHanceIT is filed under product code DQY, percutaneous catheters. The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
IMDS filed from Roden, Netherlands. The decision came 176 calendar days after receipt (February 19 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- IMDS Operation B.V.
- Product code
- Product code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roden, NL
Recent devices under product code DQY
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.