FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Branchor X Balloon Guide Catheter
K Number: K251240
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
84
Review Days
59
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Basic Information
- Device Name
- Branchor X Balloon Guide Catheter
- K Number
- K251240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asahi Intecc Co., Ltd.
- Date Received
- April 22, 2025
- Decision Date
- June 20, 2025
- Product Code
- QJP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
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Other Clearances by Asahi Intecc Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254178 | SAYA 86 Radial Access Guide Catheter | May 11, 2026 | Substantially Equivalent |
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| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Jun 20, 2025 | Substantially Equivalent |
| K243383 | CHIKAI Nexus 014 | Apr 21, 2025 | Substantially Equivalent |
| K243733 | SION blue PLUS | Apr 2, 2025 | Substantially Equivalent |
| K241962 | Crossloop | Mar 27, 2025 | Substantially Equivalent |
| K242597 | CROSSLEAD 0.018inch | Mar 5, 2025 | Substantially Equivalent |
| K241702 | CROSSLEAD 0.014inch | Feb 6, 2025 | Substantially Equivalent |
| K241801 | Tornus ES | Dec 17, 2024 | Substantially Equivalent |
| K241510 | CROSSLEAD Tracker | Aug 14, 2024 | Substantially Equivalent |