510(k) K051370
- Device
- STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
- Applicant
- Baxter Healthcare Corp
- 510(k) number
- K051370
- Product code
- JOL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-12
- Date received
- 2005-05-26
- Regulation
- 880.6740
- Classification name
- Catheter And Tip, Suction
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- NANETTE HEDDEN
- Address
- 1620 Waukegan Rd., Mpgr-Al Mcgaw Park IL US 60085 60085
FDA Registration Numbers#
- 3018366470
- 3044150131
- 1820334
- 3015142721
- 8010433
- 3004464325
- 3007007790
- 3019385708
- 9616083
- 3013557562
- 3005273623
- 3007366790
- 3010560653
- 2020735
- 8010099
- 3015479927
- 3009104075
- 3021008900
- 3010235355
- 3007441485
- 9612075
- 3021244152
- 3014936217
- 3011270181
- 3005767446
- 2210968
- 2011171
- 3010156053
- 3007840839
- 8043496
- 3016884191
- 3012507533
- 1928237
- 3008770252
- 8044099
- 1056350
- 3015183635
- 3006973666
- 3005515211
- 9611610
- 3014208300
- 3007789561
- 3013298431
- 2025917
- 1825146
- 3027150141
- 9680242
- 3014680149
- 3017171849
- 3018094310
- 3016659819
- 3015416207
- 2027062
- 3018503755
- 3006673317
- 3011052946
- 3026536498
- 3004488394
- 3010583519
- 3034669683
- 2183449
- 3010160370
- 1018233
- 3015058854
- 3020468145
- 9611102
- 9680837
- 3042172872
- 3005809810
- 3003799815
- 3014457631
- 3015309643
- 3010707607
- 1836161
- 8040233
- 3017961114
- 3043606675
- 1526439
- 9612278
- 3016452400
Source Documents#
Other 510(k) Records For Product Code JOL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 2001-05-01 |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| K974758 | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974759 | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974397 | STERILE SALINE FOR CATHETER CARE | Baxter Healthcare Corp | 1998-02-10 |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 1998-02-05 |
| K972372 | GERM TRAPPER SUCTION TUBE HOLDER | Rzv Medical Specialties, Inc. | 1997-12-11 |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | 1996-04-15 |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | 1995-12-21 |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Sherwood Medical Co. | 1995-12-15 |
| K951524 | THORACENTESIS CATHETER | Baxter Healthcare Corp | 1995-07-06 |
| K945728 | CATCO THORACIC CATHETER | Catco Medical, Inc. | 1995-05-23 |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | 1995-04-10 |