Infant Feeding Tube
FDA 510(k) K953008 · Marquette Medical, Inc.
510(k) numberK953008
Submission
- Device name
- Infant Feeding Tube
- Applicant
- Marquette Medical, Inc.
Millersville, MD, US - Received
- June 28, 1995
- Decision date
- January 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPD – Tube, Feeding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| 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 |
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|---|---|---|
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| K952976 | Plastic Blunt CannulaFPA · Traditional | 09/15/1995SE |
| K920537 | Subcutaneous Infusion SetFPA · Traditional | 10/13/1992SE |
| K905219 | 4' Low Volume IV Extension SetFPA · Traditional | 06/04/1991SE |
| K905218 | 4 Low Volume IV Extension Set with Slide ClampFPA · Traditional | 06/04/1991SE |
| K905374 | IV Extension Sets with .22 Micron FilterFPA · Traditional | 05/31/1991SE |
| K901089 | Low Volume Trifurcated IV Extension SetFPA · Traditional | 10/04/1990SE |
| K901088 | Low Volume Bifurcated IV Extension SetFPA · Traditional | 10/04/1990SE |
| K900427 | IV Trifurcated Extension SetFPA · Traditional | 02/28/1990SE |
| K900426 | IV Bifurcated Extension SetFPA · Traditional | 02/28/1990SE |
Questions and answers
When was Infant Feeding Tube cleared by the FDA?
Infant Feeding Tube (K953008) received a 510(k) decision of Substantially Equivalent on January 11, 1996, 197 days after the submission was received.
What is the product code of K953008?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.