Directvision Catheter, Uncoated

FDA 510(k) K110214 · Percuvision

Substantially Equivalent

510(k) numberK110214

Submission

Device name
Directvision Catheter, Uncoated
Applicant
Percuvision
Ashland, MA, US
Received
January 25, 2011
Decision date
May 27, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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K232469Rüsch Latex Gold Foley CatheterEZL · Traditional Teleflexmedical, Inc.08/01/2024SE
K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional Sentinel Medical Technologies, LLC04/17/2024SE
K233411Folysil Silicone CatheterEZL · Traditional Coloplast Corp.04/15/2024SE
K2330132-Way 100% Silicone Cleartract CatheterEZL · Traditional Silq Technologies Corporation01/23/2024SE
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More from Teleflexmedical, Inc.

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Questions and answers

When was Directvision Catheter, Uncoated cleared by the FDA?

Directvision Catheter, Uncoated (K110214) received a 510(k) decision of Substantially Equivalent on May 27, 2011, 122 days after the submission was received.

What is the product code of K110214?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.