Question 1

Who is the manufacturer of ORAL SUCTION CATHETER?

Accepted Answer

Ballard Medical Products filed the 510(k) submission for ORAL SUCTION CATHETER (K872283).

Question 2

What is the FDA product code for ORAL SUCTION CATHETER?

Accepted Answer

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

Question 3

When was ORAL SUCTION CATHETER cleared by the FDA?

Accepted Answer

Aug 3, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for ORAL SUCTION CATHETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ORAL SUCTION 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	K872283
Device Name	ORAL SUCTION CATHETER
Applicant	Ballard Medical Products
Product Code	BSY · Anesthesiology
Decision Date	Aug 3, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6810
Device Class	Class 1

ORAL SUCTION CATHETER

Device Facts

Regulatory Classification

Identification