SAYA 86 Radial Access Guide Catheter— 510(k) K254178
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K254178 for SAYA 86 Radial Access Guide Catheter, Substantially Equivalent on 2026-05-11. Applicant: Asahi Intecc Co., Ltd.. Device class: 2.
Summary
Asahi Intecc's SAYA 86 Radial Access Guide Catheter is filed under QJP, percutaneous neurovasculature catheters.
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.
Asahi Intecc filed from Seto, Japan. Review took 139 calendar days (December 23, 2025 to May 11, 2026).
Clearance details
- Applicant
- Asahi Intecc Co., Ltd.
- 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
- Seto, JP
Recent devices under product code QJP
view allMore clearances from Asahi Intecc Co., Ltd.
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.