Question 1

Who is the manufacturer of SUCTION CATHETER?

Accepted Answer

Medi-Craft , Ltd. filed the 510(k) submission for SUCTION CATHETER (K800503).

Question 2

What is the FDA product code for 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 SUCTION CATHETER cleared by the FDA?

Accepted Answer

Mar 18, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for SUCTION CATHETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like 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	K800503
Device Name	SUCTION CATHETER
Applicant	Medi-Craft , Ltd.
Product Code	BSY · Anesthesiology
Decision Date	Mar 18, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6810
Device Class	Class 1

SUCTION CATHETER

Device Facts

Regulatory Classification

Identification