Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM
Summary
Access Vascular, Inc. received 510(k) clearance for Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM), a LJS device. Cleared on 2025-07-01.
Details
Source
510(k) Clearance
External ID
K251212
Action Date
2025-07-01
Status
Special
Category
device
Product Code
LJS
Product Description
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM). Product code: LJS.
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. Access Vascular, Inc. has received 6 total clearances in our database.
Access Vascular, Inc. has 15 FDA actions in our database, including 9 recalls and 6 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 Access Vascular, Inc. have FDA actions?
Access Vascular, Inc. has 15 FDA actions in our database, including 9 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251212" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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