PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort
Summary
Bard Peripheral Vascular, Inc. received 510(k) clearance for PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port, a LJT device. Cleared on 2023-12-08.
Details
Source
510(k) Clearance
External ID
K232737
Action Date
2023-12-08
Status
Special
Category
device
Product Code
LJT
Product Description
PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port. Product code: LJT.
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. Bard Peripheral Vascular, Inc. has received 9 total clearances in our database.
Bard Peripheral Vascular, Inc. has 42 FDA actions in our database, including 33 recalls and 9 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 Bard Peripheral Vascular, Inc. have FDA actions?
Bard Peripheral Vascular, Inc. has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232737" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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