Firefighter NC Pro PTCA Balloon Catheter
Summary
Shanghai MicroPort Medical (Group) Co., Ltd. received 510(k) clearance for Firefighter NC Pro PTCA Balloon Catheter, a LOX device. Cleared on 2023-07-21.
Details
Source
510(k) Clearance
External ID
K223189
Action Date
2023-07-21
Status
Traditional
Category
device
Product Code
LOX
Product Description
Firefighter NC Pro PTCA Balloon Catheter. Product code: LOX.
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 Medical (Group) Co., Ltd. has received 2 total clearances in our database.
Shanghai MicroPort Medical (Group) 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 Medical (Group) Co., Ltd. have FDA actions?
Shanghai MicroPort Medical (Group) 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 "K223189" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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