CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set— 510(k) K262398
Substantially EquivalentCERENOVUS, 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.
Summary
Cerenovus's submission lists the CEREGLIDE 57 Intermediate Catheter and a Cerenovus Aspiration Tubing set. They're filed under product code NRY, thrombus retriever catheters.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
Cerenovus filed from Miami, Florida. The decision came 30 calendar days after receipt (July 14 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- CERENOVUS, Inc.
- Product code
- Product 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 all- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing
- K262399 — Millipede System
- K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)
More 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.