510(k) K954218
- Device
- STERILE FEEDING TUBE
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K954218
- Product code
- FPD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-03
- Date received
- 1995-09-08
- Regulation
- 876.5980
- Classification name
- Tube, Feeding
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ELLEN SNYDER
- Address
- Rte. 120 And Wilson Rd. Round Lake IL US 60073 60073
FDA Registration Numbers#
- 3006795797
- 9681384
- 3009698186
- 3007138831
- 1221765
- 3011987967
- 2245270
- 3009888344
- 9611665
- 3011270181
- 1060680
- 2528981
- 3008311916
- 1220477
- 3014315664
- 1043214
- 9611594
- 3003681915
- 2029015
- 8020785
- 3005483737
- 1223004
- 3009291251
- 1422634
- 3005099803
- 1055236
- 8030107
- 3010331226
- 3011237770
- 3003627840
- 8022210
- 3007084575
- 3014663754
- 3014421917
- 3008806809
- 1643817
- 3018094310
- 3002808467
- 2011171
- 3010131137
- 3011137372
- 3012494290
- 2080225
- 1054241
- 3004569180
- 2936999
- 3010041511
- 3004365956
Source Documents#
Other 510(k) Records For Product Code FPD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243361 | Nutrifit | Vygon USA | 2024-12-19 |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019-01-18 |
| K131590 | INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE | Philips Medical Systems | 2013-10-23 |
| K120815 | INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE | Philips Medical Systems | 2013-03-06 |
| K121105 | NUTRISAFE 2 FEEDING TUBE | Vygon Corp. | 2012-12-18 |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | Vygon Corp. | 2011-10-13 |
| K110853 | VR MEDICAL ENTERAL ORAL SYRINGE | Vr Medical | 2011-05-13 |
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | Benlan, Inc. | 2010-12-13 |
| K101214 | GUARDIAN CONNECTION | Maulin Medical, LLC | 2010-07-23 |
| K100099 | ORAL/ENTERAL SYRINGES | Philips Children'S Medical Ventures | 2010-06-14 |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | Kentec Medical, Inc. | 2010-04-22 |
| K091340 | THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 | Boston Scientific Corp | 2009-06-09 |
| K083776 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S | Corpak Medsystems | 2009-03-05 |
| K083791 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S | Corpak Medsystems | 2009-03-04 |
| K083786 | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB | Corpak Medsystems | 2009-02-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases