Question 1

Who is the manufacturer of KIT PAK SUCTION CATHETER KIT?

Accepted Answer

Kit Pak, Inc. filed the 510(k) submission for KIT PAK SUCTION CATHETER KIT (K885131).

Question 2

What is the FDA product code for KIT PAK SUCTION CATHETER KIT?

Accepted Answer

BSY. It is classified under 21 CFR 868.6810 as a Class 1 device in the Anesthesiology panel.

Question 3

When was KIT PAK SUCTION CATHETER KIT cleared by the FDA?

Accepted Answer

Jan 9, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for KIT PAK SUCTION CATHETER KIT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like KIT PAK SUCTION CATHETER KIT?

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	K885131
Device Name	KIT PAK SUCTION CATHETER KIT
Applicant	Kit Pak, Inc.
Product Code	BSY · Anesthesiology
Decision Date	Jan 9, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6810
Device Class	Class 1

KIT PAK SUCTION CATHETER KIT

Device Facts

Regulatory Classification

Identification