Angiographic Needle

FDA 510(k) K831189 · Medrad, Inc.

Substantially Equivalent

510(k) numberK831189

Submission

Device name
Angiographic Needle
Applicant
Medrad, Inc.
Walker, MI, US
Received
April 12, 1983
Decision date
May 9, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Angiographic Needle cleared by the FDA?

Angiographic Needle (K831189) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 27 days after the submission was received.

What is the product code of K831189?

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