510(k) clearance
70 NeuGlide Catheter
- 510(k) number
- K262277
- Applicant
- Piraeus Medical, Inc.
- Decision date
- Sep 4, 2026
- Date received
- Jul 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QJP
- Device type
- Catheter, Percutaneous, Neurovasculature
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Maple Grove, MN, US