4F-7F Medi-Dyne Torq Flow XLB Angiographic Catheter

FDA 510(k) K000825 · Medi-Dyne, Inc.

Substantially Equivalent

510(k) numberK000825

Submission

Device name
4F-7F Medi-Dyne Torq Flow XLB Angiographic Catheter
Applicant
Medi-Dyne, Inc.
Queensbury, NY, US
Received
March 14, 2000
Decision date
September 21, 2000
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 4F-7F Medi-Dyne Torq Flow XLB Angiographic Catheter cleared by the FDA?

4F-7F Medi-Dyne Torq Flow XLB Angiographic Catheter (K000825) received a 510(k) decision of Substantially Equivalent on September 21, 2000, 191 days after the submission was received.

What is the product code of K000825?

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