Question 1

Who is the manufacturer of GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP?

Accepted Answer

Pilling Co. filed the 510(k) submission for GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP (K761169).

Question 2

What is the FDA product code for GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP?

Accepted Answer

DXC. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

Question 3

When was GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP cleared by the FDA?

Accepted Answer

Dec 9, 1976 (decision: SESE).

Question 4

What is the regulatory pathway for GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP?

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	K761169
Device Name	GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP
Applicant	Pilling Co.
Product Code	DXC · Cardiovascular
Decision Date	Dec 9, 1976
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2

GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP

Device Facts

Regulatory Classification

Identification