Cardiovascular, Thermodilution, Flow, Coronary Sin

FDA 510(k) K853383 · Webster Laboratories, Inc.

Substantially Equivalent

510(k) numberK853383

Submission

Device name
Cardiovascular, Thermodilution, Flow, Coronary Sin
Applicant
Webster Laboratories, Inc.
Baldwin Park, CA, US
Received
August 12, 1985
Decision date
December 3, 1985
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
K841802Electrode Catheter, Orthogonal TypeLDF · Traditional 10/18/1984SE
K834602Switching Unit Electrode CatheterDRF · Traditional 05/09/1984SE
K823361Switching Unit Electrode CathetersDRF · Traditional 01/14/1983SE
K813271Temperature ProbesKRI · Traditional 12/29/1981SE

Questions and answers

When was Cardiovascular, Thermodilution, Flow, Coronary Sin cleared by the FDA?

Cardiovascular, Thermodilution, Flow, Coronary Sin (K853383) received a 510(k) decision of Substantially Equivalent on December 3, 1985, 113 days after the submission was received.

What is the product code of K853383?

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