Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapL
Summary
Vascular Solutions, LLC received 510(k) clearance for Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter, a DQY device. Cleared on 2022-02-09.
Details
Source
510(k) Clearance
External ID
K212211
Action Date
2022-02-09
Status
Traditional
Category
device
Product Code
DQY
Product Description
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter. Product code: DQY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Vascular Solutions, LLC has received 4 total clearances in our database.
Vascular Solutions, LLC has 4 FDA actions in our database, including 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Vascular Solutions, LLC have FDA actions?
Vascular Solutions, LLC has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212211" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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