JOL · Catheter And Tip, Suction
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | JOL |
|---|---|
| Device Name | Catheter And Tip, Suction |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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).
Classification Rationale
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.
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.
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051370 | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | Baxter Healthcare Corp | Aug 12, 2005 | SESE |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Primary Care Solutions, Inc. | Jul 12, 2001 | SESE |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | Jul 12, 2001 | SESE |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | May 1, 2001 | SESE |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | Oct 25, 2000 | SESE |
| K974759 | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Hydrox Laboratories | Mar 9, 1998 | SESE |
| K974758 | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Hydrox Laboratories | Mar 9, 1998 | SESE |
| K974397 | STERILE SALINE FOR CATHETER CARE | Baxter Healthcare Corp | Feb 10, 1998 | SESE |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | Feb 5, 1998 | SESE |
| K972372 | GERM TRAPPER SUCTION TUBE HOLDER | Rzv Medical Specialties, Inc. | Dec 11, 1997 | SESE |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | Apr 15, 1996 | SESE |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | Dec 21, 1995 | SESE |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Sherwood Medical Co. | Dec 15, 1995 | SESE |
| K951524 | THORACENTESIS CATHETER | Baxter Healthcare Corp | Jul 6, 1995 | SESE |
| K945728 | CATCO THORACIC CATHETER | Catco Medical, Inc. | May 23, 1995 | SESE |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | Apr 10, 1995 | SESE |
| K943773 | STERILE WATER | Medline Industries, Inc. | Feb 27, 1995 | SESE |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | Orion Life Systems, Inc. | Nov 21, 1994 | SESE |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | Orion Life Systems, Inc. | Nov 21, 1994 | SESE |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Orion Life Systems, Inc. | Nov 21, 1994 | SESE |
Top Applicants
- Orion Life Systems, Inc. — 8 clearances
- Baxter Healthcare Corp — 4 clearances
- Sherwood Medical Co. — 4 clearances
- Arrow Intl., Inc. — 2 clearances
- Deknatel, Inc. — 2 clearances
