Hemostatic Side-Arm Adapter

FDA 510(k) K813578 · Advanced Catheter Systems

Substantially Equivalent

510(k) numberK813578

Submission

Device name
Hemostatic Side-Arm Adapter
Applicant
Advanced Catheter Systems
Mchenry, IL, US
Received
December 23, 1981
Decision date
January 18, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DYG – Catheter, Flow Directed
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1240
Specialty
Cardiovascular

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More from Transonic Systems, Inc.

510(k)DeviceDecision
K813577Pressure Indicator-RegulatorDQO · Traditional 01/29/1982SE
K813624Advanced Catheter Systems Coronary GuidDQO · Traditional 01/22/1982SE
K813623Simpson-Robert Coronary Guiding CathetDQO · Traditional 01/22/1982SE
K813622IndeflatorDQO · Traditional 01/22/1982SE

Questions and answers

When was Hemostatic Side-Arm Adapter cleared by the FDA?

Hemostatic Side-Arm Adapter (K813578) received a 510(k) decision of Substantially Equivalent on January 18, 1982, 26 days after the submission was received.

What is the product code of K813578?

The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.