Assert-IQ (DM5100)— 510(k) K253516
Substantially EquivalentABBOTT MEDICAL
FDA 510(k) clearance K253516 for Assert-IQ (DM5100), Substantially Equivalent on 2025-12-18. Applicant: ABBOTT MEDICAL.
Clearance details
- Applicant
- ABBOTT MEDICAL
- Product code
- Code MXD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sylmar, CA, US
Adverse events under product code MXD
product code MXD- Injury
- 1,880
- Malfunction
- 9,487
- Total
- 11,367
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.