Question 1

Who is the manufacturer of SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]?

Accepted Answer

Baxter Healthcare Corp filed the 510(k) submission for SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] (K951566).

Question 2

What is the FDA product code for SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]?

Accepted Answer

DYG. It is classified under 21 CFR 870.1240 as a Class 2 device in the Cardiovascular panel.

Question 3

When was SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] cleared by the FDA?

Accepted Answer

Nov 27, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K951566
Device Name	SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
Applicant	Baxter Healthcare Corp
Product Code	DYG · Cardiovascular
Decision Date	Nov 27, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1240
Device Class	Class 2

SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]

Device Facts

Regulatory Classification

Identification