Neich NM Advance Catheter Sheath Introducer

FDA 510(k) K020964 · Neich Medical(Shenzhen)Company, Ltd.

Substantially Equivalent

510(k) numberK020964

Submission

Device name
Neich NM Advance Catheter Sheath Introducer
Applicant
Neich Medical(Shenzhen)Company, Ltd.
Shenzhen, CN
Received
March 25, 2002
Decision date
October 11, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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Questions and answers

When was Neich NM Advance Catheter Sheath Introducer cleared by the FDA?

Neich NM Advance Catheter Sheath Introducer (K020964) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 200 days after the submission was received.

What is the product code of K020964?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.