Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
Summary
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular received 510(k) clearance for Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing, a JCX device. Cleared on 2024-12-02.
Details
Source
510(k) Clearance
External ID
K243418
Action Date
2024-12-02
Status
Special
Category
device
Product Code
JCX
Product Description
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing. Product code: JCX.
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. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has received 5 total clearances in our database.
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has 5 FDA actions in our database, including 5 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 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular have FDA actions?
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243418" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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