Crossing Support Catheter

FDA 510(k) K183305 · Tractus Vascular, LLC

Substantially Equivalent

510(k) numberK183305

Submission

Device name
Crossing Support Catheter
Applicant
Tractus Vascular, LLC
Eatontown, NJ, US
Received
November 28, 2018
Decision date
August 5, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was Crossing Support Catheter cleared by the FDA?

Crossing Support Catheter (K183305) received a 510(k) decision of Substantially Equivalent on August 5, 2019, 250 days after the submission was received.

What is the product code of K183305?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.