FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
K Number: K212167
·
Decision Feb 9, 2022
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
11
Review Days
212
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Basic Information
- Device Name
- R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
- K Number
- K212167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, LLC
- Date Received
- July 12, 2021
- Decision Date
- February 9, 2022
- 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, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | May 31, 2024 | Substantially Equivalent |
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| K221470 | Langston dual lumen catheter | Jun 17, 2022 | Substantially Equivalent |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | Feb 9, 2022 | Substantially Equivalent |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | Apr 30, 2021 | Substantially Equivalent |
| K193119 | Twin-Pass Dual Access Catheter | Jun 29, 2020 | Substantially Equivalent |
| K200720 | D-Stat Radial Topical Hemostat | Jun 26, 2020 | Substantially Equivalent |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Aug 9, 2019 | Substantially Equivalent |
| K182570 | Venture 0.014 Catheter | Mar 13, 2019 | Substantially Equivalent |