Creation NM Diagnostic Catheters

FDA 510(k) K032888 · Neich Medical (Shenzhen) Company Limited

Substantially Equivalent

510(k) numberK032888

Submission

Device name
Creation NM Diagnostic Catheters
Applicant
Neich Medical (Shenzhen) Company Limited
Shenzhen, CN
Received
September 16, 2003
Decision date
February 24, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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Questions and answers

When was Creation NM Diagnostic Catheters cleared by the FDA?

Creation NM Diagnostic Catheters (K032888) received a 510(k) decision of Substantially Equivalent on February 24, 2004, 161 days after the submission was received.

What is the product code of K032888?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.