p17 XR Microcatheter— 510(k) K254071
Substantially EquivalentWallaby Medical
FDA 510(k) clearance K254071 for p17 XR Microcatheter, Substantially Equivalent on 2026-08-18. Applicant: Wallaby Medical. Device class: 2.
Summary
Wallaby Medical's p17 XR Microcatheter is filed under product code QJP, percutaneous neurovasculature catheters. The record doesn't say what p17 or XR refers to.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Wallaby filed from Laguna Hills, California. The decision came 243 calendar days after FDA received it (December 18, 2025 to August 18, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Wallaby Medical
- 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
- Laguna Hills, CA, US
Recent devices under product code QJP
view allMore clearances from Wallaby Medical
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.