Churchill 1.2 Micron Liquid Filter Set
FDA 510(k) K880027 · Churchill Corp.
510(k) numberK880027
Submission
- Device name
- Churchill 1.2 Micron Liquid Filter Set
- Applicant
- Churchill Corp.
Langhorne, PA, US - Received
- January 5, 1988
- Decision date
- April 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A…FPB · Traditional | Global Life Sciences Solutions USA, LLC | 08/31/2026SE |
| K233277 | Filter Needle for Single UseFPB · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 05/10/2024SE |
| K143583 | Cathivex ¿GV filter unitsFPB · Traditional | Merck Millipore , Ltd. | 08/11/2015SE |
| K113227 | Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterFPB · Special | Baxter Healthcare Corp | 12/08/2011SE |
| K021293 | Arteria Blood FilterFPB · Traditional | Arteria Medical Science, Inc. | 08/22/2002SE |
| K993379 | Pall Supor Aef FilterFPB · Traditional | Pall Corp. | 12/16/1999SE |
| K974661 | 0.2 U Bacterial FilterFPB · Traditional | Sims Deltec, Inc. | 02/11/1998SE |
| K964283 | AutoprimeFPB · Traditional | Arbor Technologies, Inc. | 01/22/1997SE |
| K954331 | Pall Lea Filter (Lipid Emulsion Filter) (I.V. Filter)FPB · Traditional | Pall Biomedical Products Co. | 01/09/1997SE |
| K933523 | I.V. Filter SetFPB · Traditional | Mediziv Medical Products 1987 , Ltd. | 05/19/1995SE |
More from Mediziv Medical Products 1987 , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K880051 | Enteral Bag/SetKNT · Traditional | 04/14/1988SE |
| K880026 | Churchill 0.22 Micron Liquid Compact Filter SetsFPB · Traditional | 04/14/1988SE |
| K880025 | Churchill 0.22 Micron Liquid Filter SetsFPB · Traditional | 04/14/1988SE |
| K872585 | Churchill-CathFOZ · Traditional | 10/15/1987SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | 10/15/1987SE |
| K872124 | Churchill Albumin IV Administration SetFPA · Traditional | 10/13/1987SE |
| K872123 | Churchill TPN Administration SetFPA · Traditional | 10/09/1987SE |
| K872043 | Churchill Inter-Cardiac SuckerDWF · Traditional | 09/30/1987SE |
| K871084 | Nitroglycerine Pump SetFRN · Traditional | 07/16/1987SE |
| K871732 | Churchill-H Vented IV Set W/Metering ChambersFPA · Traditional | 06/15/1987SE |
Questions and answers
When was Churchill 1.2 Micron Liquid Filter Set cleared by the FDA?
Churchill 1.2 Micron Liquid Filter Set (K880027) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 99 days after the submission was received.
What is the product code of K880027?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.