XableCath Support Catheter

FDA 510(k) K170041 · Xablecath, Inc.

Substantially Equivalent

510(k) numberK170041

Submission

Device name
XableCath Support Catheter
Applicant
Xablecath, Inc.
Salt Lake City, UT, US
Received
January 5, 2017
Decision date
September 7, 2017
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 XableCath Support Catheter cleared by the FDA?

XableCath Support Catheter (K170041) received a 510(k) decision of Substantially Equivalent on September 7, 2017, 245 days after the submission was received.

What is the product code of K170041?

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