FDA 510(k) Premarket Notification K924661: SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

Submission Details & Decision

Normalized public record details for 510(k) notification K924661.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K924661

Applicant / Sponsor

Baxter Healthcare Corp

Device Name

SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

Product Code

KRA

Decision Date

1993-04-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1992-09-15

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