Product Code: BYY FDA class 2 21 CFR 880.6740

Tube, Aspirating, Flexible, Connecting

General Hospital

The Tube, Aspirating, Flexible, Connecting is a flexible tube used to connect suction sources to suction devices or catheters for aspiration of fluids in clinical settings. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BYY, regulated under 21 CFR 880.6740 in the General Hospital specialty.

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510(k)s

FEI Numbers

174

Registration Numbers

174

Unique Applicants

Years Active

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Basic Information

Product Code: BYY
Device Class: FDA class 2
Regulation Number: 880.6740
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960616	VITAFLOW SUCTION/ASPIRATION TUBING SET	May 06, 1996	Substantially Equivalent	Vital Concepts, Inc.
K960218	CONNECTING TUBING	Mar 28, 1996	Substantially Equivalent	Custom Pack Reliability
K955151	MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR	Jan 24, 1996	Substantially Equivalent	Bio-Medical Devices, Inc.
K955149	MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL	Jan 24, 1996	Substantially Equivalent	Bio-Medical Devices, Inc.
K955150	MAXI-FLOW	Jan 23, 1996	Substantially Equivalent	Bio-Medical Devices, Inc.
K922989	WILTEK IRRIGAITON/ASPIRATION TUBE SET	Feb 15, 1994	Substantially Equivalent	Wiltek Medical, Inc.
K911586	GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)	Jul 02, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K901761	STERILE SUCTION TUBING SET	May 07, 1990	Substantially Equivalent	Acacia Laboratories, Inc.
K873463	VAN DELLEN ASPIRATING TUBING	Nov 23, 1987	Substantially Equivalent	Van Dellen, Ltd.
K853296	EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN	Aug 15, 1985	Substantially Equivalent	Parexel Intl. Corp.
K843470	PHARMA-PLAST CONNECTING TUBE TYPE SUCT-	Nov 16, 1984	Substantially Equivalent	Zimmar Consulting , Ltd.
K832865	FLEX BUBBLE TUBING	Sep 29, 1983	Substantially Equivalent	Sheridan Catheter Corp.
K832398	DYNACOR CONNECTING TUBING	Aug 24, 1983	Substantially Equivalent	Medline Industries, Inc.
K831920	PLASTIC TUBING CONNECTORS	Jul 19, 1983	Substantially Equivalent	Polymer Technology Corp.
K821703	MGN CONDUCTIVE CONNECTING TUBE, STERILE	Jun 22, 1982	Substantially Equivalent	Mgn Medical Manufacturing, Inc.
K820371	PLASTIC CONNECTORS	Apr 01, 1982	Substantially Equivalent	American Pharmaseal Div. Ahsc
K820412	AM. PH. STERILE PLASTIC CONNECTING TUBES	Mar 31, 1982	Substantially Equivalent	American Pharmaseal Div. Ahsc
K813228	CONNECTING TUBE	Nov 27, 1981	Substantially Equivalent	Northern Medical Industries
K811541	MGN CONNECTING TUBE	Jun 18, 1981	Substantially Equivalent	Mgn Medical Manufacturing, Inc.
K800235	ABCO CONNECTING TUBES PRECUT LENGTHS	Feb 26, 1980	Substantially Equivalent	Abco Dealers, Inc.
K790420	SUCTION CONNECTING TUBING	Apr 23, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K790419	YANKAUER & POODLE SUCTION INSTRUMENTS	Apr 23, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K780724	BUBBLE SUCTION TUBING	Jun 02, 1978	Substantially Equivalent	Davol, Inc.
K761079	FLEXIBLE TIP ASPIRATING TUBES	Dec 09, 1976	Substantially Equivalent	Pilling Co.