SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
Summary
Spectrum Vascular received 510(k) clearance for SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter, a FOZ device. Cleared on 2024-11-27.
Details
Source
510(k) Clearance
External ID
K241115
Action Date
2024-11-27
Status
Traditional
Category
device
Product Code
FOZ
Product Description
SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter. Product code: FOZ.
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. Spectrum Vascular has received 4 total clearances in our database.
Spectrum Vascular 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 Spectrum Vascular have FDA actions?
Spectrum Vascular 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 "K241115" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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