70 NeuGlide Catheter— 510(k) K262277
Substantially EquivalentPiraeus Medical, Inc.
FDA 510(k) clearance K262277 for 70 NeuGlide Catheter, Substantially Equivalent on 2026-09-04. Applicant: Piraeus Medical, Inc.. Device class: 2.
Summary
The 70 NeuGlide Catheter from Piraeus Medical is filed under QJP, percutaneous neurovasculature catheters. The record doesn't say what the "70" refers to or give dimensions.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k); the record lists Cardiovascular as the classification panel.
Piraeus Medical filed from Maple Grove, Minnesota. The decision came 60 calendar days after receipt (July 6 to September 4, 2026).
Clearance details
- Applicant
- Piraeus Medical, Inc.
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code QJP
view allMore clearances from Piraeus Medical, Inc.
view allAdverse 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.