Question 1

Who is the manufacturer of SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7?

Accepted Answer

Baxter Healthcare Corp filed the 510(k) submission for SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 (K001063).

Question 2

What is the FDA product code for SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7?

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-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 cleared by the FDA?

Accepted Answer

Jul 7, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7?

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	K001063
Device Name	SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
Applicant	Baxter Healthcare Corp
Product Code	DYG · Cardiovascular
Decision Date	Jul 7, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1240
Device Class	Class 2

SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

Device Facts

Regulatory Classification

Identification