FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spectre guidewire
K Number: K163444
·
Decision Jan 6, 2017
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
103
Review Days
29
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Basic Information
- Device Name
- Spectre guidewire
- K Number
- K163444
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- December 8, 2016
- Decision Date
- January 6, 2017
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Vascular Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182232 | Octane Mechanical Thrombectomy System | Sep 11, 2018 | Substantially Equivalent |
| K181647 | Bandit guidewire | Jul 20, 2018 | Substantially Equivalent |
| K180913 | VSI Micro-Introducer Kit | May 9, 2018 | Substantially Equivalent |
| K180088 | TrapLiner catheter | Apr 4, 2018 | Substantially Equivalent |
| K180128 | Warrior 14 guidewire | Feb 16, 2018 | Substantially Equivalent |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Jan 19, 2018 | Substantially Equivalent |
| K173532 | Raider Guidewire | Dec 15, 2017 | Substantially Equivalent |
| K173266 | Octane aspiration system | Dec 1, 2017 | Substantially Equivalent |
| K170544 | Langston dual lumen catheter | Nov 17, 2017 | Substantially Equivalent |
| K171946 | Gel-Bead | Oct 25, 2017 | Substantially Equivalent |