Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set— 510(k) K233988
Substantially EquivalentCerenovus, Inc.
FDA 510(k) clearance K233988 for Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set, Substantially Equivalent on 2024-01-17. 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
Recent devices under product code NRY
view allMore clearances from Cerenovus, Inc.
view all- K262419 — MICRUSFRAME (19+ models)
- K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
- K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
- K233982 — CEREGLIDE 92 Catheter System
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.