Spartan Center Wire

FDA 510(k) K220075 · Spartan Micro, Inc.

Substantially Equivalent

510(k) numberK220075

Submission

Device name
Spartan Center Wire
Applicant
Spartan Micro, Inc.
Costa Mesa, CA, US
Received
January 10, 2022
Decision date
April 19, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQX – Wire, Guide, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

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Questions and answers

When was Spartan Center Wire cleared by the FDA?

Spartan Center Wire (K220075) received a 510(k) decision of Substantially Equivalent on April 19, 2022, 99 days after the submission was received.

What is the product code of K220075?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.