EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
Summary
Shanghai Microport EP Medtech Co., Ltd. received 510(k) clearance for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter, a DRF device. Cleared on 2022-12-30.
Details
Source
510(k) Clearance
External ID
K210313
Action Date
2022-12-30
Status
Traditional
Category
device
Product Code
DRF
Product Description
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter. Product code: DRF.
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. Shanghai Microport EP Medtech Co., Ltd. has received 2 total clearances in our database.
Shanghai Microport EP Medtech Co., Ltd. has 2 FDA actions in our database, including 2 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 Shanghai Microport EP Medtech Co., Ltd. have FDA actions?
Shanghai Microport EP Medtech Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K210313" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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