Excelsior Reach Microcatheter— 510(k) K261649
Substantially EquivalentStryker Neurovascular
FDA 510(k) clearance K261649 for Excelsior Reach Microcatheter, Substantially Equivalent on 2026-10-09. Applicant: Stryker Neurovascular. Device class: 2.
Summary
The Excelsior Reach Microcatheter is from Stryker Neurovascular, filed under QJP, percutaneous neurovasculature catheters. The record doesn't describe its dimensions or what "Reach" refers to.
It's Class II under 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Stryker Neurovascular filed from Fremont, California. Review took 143 days (May 19 to October 9, 2026).
Clearance details
- Applicant
- Stryker Neurovascular
- 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
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code QJP
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view all- K261889 — Trevo Trak 21 Microcatheter
- K253032 — AXS Lift Intracranial Base Catheter
- K252694 — Target Detachable Coil
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
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.