L.T.C. Enteral Bag Administration Set W/Pump Set
FDA 510(k) K895824 · Intl. Medical Marketing, Inc.
510(k) numberK895824
Submission
- Device name
- L.T.C. Enteral Bag Administration Set W/Pump Set
- Applicant
- Intl. Medical Marketing, Inc.
Ridge, NY, US - Received
- September 29, 1989
- Decision date
- March 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPD – Tube, Feeding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FPD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K120815 | Innersense Esophageal Temperature/Feeding TubeFPD · Traditional | Philips Medical Systems | 03/06/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
More from Philips Children'S Medical Ventures
| 510(k) | Device | Decision |
|---|---|---|
| K897181 | L.T.C. Percutaneous Endoscopic Gastrostomy TubeFPD · Traditional | 03/27/1990SESD |
| K896621 | L.T.C. Replacement Gastrostomy TubeKCQ · Traditional | 03/13/1990SE |
| K895957 | L.T.C. 1000 Urinary Drainage BagKNX · Traditional | 10/24/1989SE |
| K895616 | L.T.C. Feeding TubeKNT · Traditional | 10/24/1989SE |
Questions and answers
When was L.T.C. Enteral Bag Administration Set W/Pump Set cleared by the FDA?
L.T.C. Enteral Bag Administration Set W/Pump Set (K895824) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 165 days after the submission was received.
What is the product code of K895824?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.