JOL — Catheter And Tip, Suction Class II
FDA product code JOL covers "Catheter And Tip, Suction", a Class II medical device regulated under 21 CFR 880.6740. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOL
- Device Class
- Class II
- Regulation Number
- 880.6740
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K051370 | Baxter Healthcare | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F | Aug 12, 2005 |
| K000266 | Primary Care Solutions | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Jul 12, 2001 |
| K000265 | Primary Care Solutions | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Jul 12, 2001 |
| K003402 | Welcon | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO | May 1, 2001 |
| K994321 | Automatic Liquid Packaging | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Oct 25, 2000 |
| K974758 | Hydrox Laboratories | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Mar 9, 1998 |
| K974759 | Hydrox Laboratories | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Mar 9, 1998 |
| K974397 | Baxter Healthcare | STERILE SALINE FOR CATHETER CARE | Feb 10, 1998 |
| K973734 | Welcon | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Feb 5, 1998 |
| K972372 | Rzv Medical Specialties | GERM TRAPPER SUCTION TUBE HOLDER | Dec 11, 1997 |
| K960216 | Custom Pack Reliability | CPR SUCTION CATHETER KIT | Apr 15, 1996 |
| K954442 | Medcare Custom Packaging | STERILE ISOTONIC SALINE & STERILE WATER | Dec 21, 1995 |
| K950201 | Sherwood Medical | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 |
| K951524 | Baxter Healthcare | THORACENTESIS CATHETER | Jul 6, 1995 |
| K945728 | Catco Medical | CATCO THORACIC CATHETER | May 23, 1995 |
| K943661 | Medcare Custom Packaging | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Apr 10, 1995 |
| K943773 | Medline Industries | STERILE WATER | Feb 27, 1995 |
| K943834 | Orion Life Systems | STERILE .9% SODIUM CHLORIDE SOLUTION | Nov 21, 1994 |
| K943829 | Orion Life Systems | PRE-FILLED SYSRINGE W/STERILE WATER | Nov 21, 1994 |
| K943832 | Orion Life Systems | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Nov 21, 1994 |