Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7

FDA 510(k) K001063 · Baxter Healthcare Corp

Substantially Equivalent

510(k) numberK001063

Submission

Device name
Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7
Applicant
Baxter Healthcare Corp
Irvine, CA, US
Received
April 3, 2000
Decision date
July 7, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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Questions and answers

When was Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7 cleared by the FDA?

Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7 (K001063) received a 510(k) decision of Substantially Equivalent on July 7, 2000, 95 days after the submission was received.

What is the product code of K001063?

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