Question 1

Who is the manufacturer of CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER?

Accepted Answer

Arrow Intl., Inc. filed the 510(k) submission for CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER (K884552).

Question 2

What is the FDA product code for CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER?

Accepted Answer

CAZ. It is classified under 21 CFR 868.5140 as a Class 2 device in the Anesthesiology panel.

Question 3

When was CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER cleared by the FDA?

Accepted Answer

Mar 14, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER?

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	K884552
Device Name	CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
Applicant	Arrow Intl., Inc.
Product Code	CAZ · Anesthesiology
Decision Date	Mar 14, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5140
Device Class	Class 2

CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER

Device Facts

Regulatory Classification

Identification