35 Helix Guidewire— 510(k) K260751
Substantially EquivalentPiraeus Medical, Inc.
FDA 510(k) clearance K260751 for 35 Helix Guidewire, Substantially Equivalent on 2026-08-27. Applicant: Piraeus Medical, Inc.. Device class: 2.
Summary
Piraeus Medical's 35 Helix Guidewire is filed under product code MOF, neurovasculature catheter guide wires. The record doesn't say what 35 refers to in the name.
Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Piraeus filed from Maple Grove, Minnesota. The decision came 174 calendar days after FDA received it (March 6 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Piraeus Medical, Inc.
- Product code
- Product code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code MOF
view allMore clearances from Piraeus Medical, Inc.
view allAdverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
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.