Question 1

Who is the manufacturer of EXACTA PERCUTANEOUS INTRODUCER SHEATH?

Accepted Answer

Ohmeda Medical filed the 510(k) submission for EXACTA PERCUTANEOUS INTRODUCER SHEATH (K941428).

Question 2

What is the FDA product code for EXACTA PERCUTANEOUS INTRODUCER SHEATH?

Accepted Answer

DYB. It is classified under 21 CFR 870.1340 as a Class 2 device in the Cardiovascular panel.

Question 3

When was EXACTA PERCUTANEOUS INTRODUCER SHEATH cleared by the FDA?

Accepted Answer

Jul 6, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for EXACTA PERCUTANEOUS INTRODUCER SHEATH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EXACTA PERCUTANEOUS INTRODUCER SHEATH?

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	K941428
Device Name	EXACTA PERCUTANEOUS INTRODUCER SHEATH
Applicant	Ohmeda Medical
Product Code	DYB · Cardiovascular
Decision Date	Jul 6, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1340
Device Class	Class 2

EXACTA PERCUTANEOUS INTRODUCER SHEATH

Device Facts

Regulatory Classification

Identification