SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Summary
Cordis US Corp received 510(k) clearance for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter, a LIT device. Cleared on 2022-08-22.
Details
Source
510(k) Clearance
External ID
K221832
Action Date
2022-08-22
Status
Traditional
Category
device
Product Code
LIT
Product Description
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter. Product code: LIT.
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. Cordis US Corp has received 4 total clearances in our database.
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 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 Cordis US Corp have FDA actions?
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221832" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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