CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set— 510(k) K262398

Substantially Equivalent

CERENOVUS, Inc.

FDA 510(k) clearance K262398 for CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set, Substantially Equivalent on 2026-08-13. Applicant: CERENOVUS, Inc.. Device class: 2.

Clearance details

Applicant
CERENOVUS, Inc.
Product code
Code NRY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NRY

product code NRY
Death
411
Injury
1,712
Malfunction
1,855
Total
3,978

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.