Saffron NM Guiding Catheter

FDA 510(k) K030715 · Neich Medical (Shenzhen) Company Limited

Substantially Equivalent

510(k) numberK030715

Submission

Device name
Saffron NM Guiding Catheter
Applicant
Neich Medical (Shenzhen) Company Limited
Shenzhen, CN
Received
March 7, 2003
Decision date
April 24, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Saffron NM Guiding Catheter cleared by the FDA?

Saffron NM Guiding Catheter (K030715) received a 510(k) decision of Substantially Equivalent on April 24, 2003, 48 days after the submission was received.

What is the product code of K030715?

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