K961880 · Medcare Medical Group, Inc. · GCX · Jul 19, 1996 · General Hospital
Device Facts
Record ID
K961880
Device Name
MEDCARE SUCTION CONNECTING TUBING
Applicant
Medcare Medical Group, Inc.
Product Code
GCX · General Hospital
Decision Date
Jul 19, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6740
Device Class
Class 2
Indications for Use
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
Device Story
Single-use disposable PVC tubing; connects suction devices (Yankauer, catheters) to vacuum collection canisters. Features injection-molded tapered PVC connectors with internal ribs for secure fitment. Used in clinical settings to facilitate fluid/debris removal via suction. Passive conduit; no active processing or electronic components.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Materials: Polyvinyl chloride (PVC). Design: Extruded tubing with solvent-bonded injection-molded tapered connectors featuring internal ribs. Form factor: Flexible tubing. Energy source: None (passive).
Indications for Use
Indicated for general suction procedures requiring a connecting conduit between a suction device (e.g., Yankauer, catheter) and a vacuum collection canister.
Regulatory Classification
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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JUL 19 1996
K96/880
(1) **510(k) Summary:**
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
(1) **Submitted By:**
MedCare Medical Group, Inc.
234 Old Homestead Highway
E. Swanzey, NH 03446
**Contact Person:**
Craig J. Bell
Director of Research and Development
(603)352-3230
(2) **Name of Device:**
Suction Connecting Tubing
**Classification Name:**
Class II device, reference 21 CFR, Part 880.6740
(3) **Identification of Predicate Devices:**
Suction Connecting Tubing
(a) Kendall Healthcare Products Company
Mansfield, MA 02048
(4) **Description of Device Subject to Premarket Notification:**
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
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(5) **Intended Use of the Device:**
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
(6) **Technological Characteristics**
The MedCare Suction Connecting Tubing is made of similar construction and similar design to the predicate device for, as the name suggests, providing a tubing connection from the suction canister to a suction device. The MedCare Suction Connecting Tubing is provided with tapered fittings to allow secure fitment to a variety of suction devices.
