Emerge Monorail PTCA Dilatation Catheter
Summary
Boston Scientific received 510(k) clearance for Emerge Monorail PTCA Dilatation Catheter, a LOX device. Cleared on 2022-03-24.
Details
Source
510(k) Clearance
External ID
K220629
Action Date
2022-03-24
Status
Special
Category
device
Product Code
LOX
Product Description
Emerge Monorail PTCA Dilatation Catheter. Product code: LOX.
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. Boston Scientific has received 15 total clearances in our database.
Boston Scientific has 15 FDA actions in our database, including 15 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 Boston Scientific have FDA actions?
Boston Scientific has 15 FDA actions in our database, including 0 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220629" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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