Question 1

Who is the manufacturer of IONESCU-SHILEY PERICARDIAL PATCH?

Accepted Answer

Shiley, Inc. filed the 510(k) submission for IONESCU-SHILEY PERICARDIAL PATCH (K801764).

Question 2

What is the FDA product code for IONESCU-SHILEY PERICARDIAL PATCH?

Accepted Answer

DXZ. It is classified under 21 CFR 870.3470 as a Class 2 device in the Cardiovascular panel.

Question 3

When was IONESCU-SHILEY PERICARDIAL PATCH cleared by the FDA?

Accepted Answer

Aug 13, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for IONESCU-SHILEY PERICARDIAL PATCH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like IONESCU-SHILEY PERICARDIAL PATCH?

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	K801764
Device Name	IONESCU-SHILEY PERICARDIAL PATCH
Applicant	Shiley, Inc.
Product Code	DXZ · Cardiovascular
Decision Date	Aug 13, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3470
Device Class	Class 2

IONESCU-SHILEY PERICARDIAL PATCH

Device Facts

Regulatory Classification

Identification