CEREGLIDE 92 Intermediate Catheter— 510(k) K230726
Substantially EquivalentCerenovus, Inc.
FDA 510(k) clearance K230726 for CEREGLIDE 92 Intermediate Catheter, Substantially Equivalent on 2023-11-29. Applicant: Cerenovus, Inc.. Device class: 2.
Clearance details
- Applicant
- Cerenovus, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code QJP
view allMore clearances from Cerenovus, Inc.
view all- K262419 — MICRUSFRAME (19+ models)
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- 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
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.