FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
K Number: K112979
·
Decision Dec 1, 2011
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
30
Applicant Total
52
Review Days
56
Basic Information
- Device Name
- ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
- K Number
- K112979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASAHI INTECC CO., LTD.
- Date Received
- October 6, 2011
- Decision Date
- December 1, 2011
- Product Code
- MOF
- 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 |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOF), ordered by most recent decision date.
CHIKAI Nexus 014
FDA 510(k)
FDA Class 2
·Cardiovascular
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Synxess Neurovascular Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Drivewire 24 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Aristotle 18 Guidewire; Aristotle 24 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartGUIDE deflectable hydrophilic guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by ASAHI INTECC CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K243383 | CHIKAI Nexus 014 | Apr 21, 2025 | Substantially Equivalent |
| K243733 | SION blue PLUS | Apr 2, 2025 | Substantially Equivalent |
| K241510 | CROSSLEAD Tracker | Aug 14, 2024 | Substantially Equivalent |
| K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES | Jul 18, 2018 | Substantially Equivalent |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | Apr 3, 2017 | Substantially Equivalent |
| K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03 | Jan 27, 2017 | Substantially Equivalent |
| K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip | Oct 14, 2016 | Substantially Equivalent |
| K161126 | ASAHI Corsair Pro | Aug 25, 2016 | Substantially Equivalent |
| K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Jun 21, 2016 | Substantially Equivalent |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Apr 7, 2016 | Substantially Equivalent |