.22 & 1.2 Micron IV Filters
FDA 510(k) K894954 · Churchill Medical Systems, Inc.
510(k) numberK894954
Submission
- Device name
- .22 & 1.2 Micron IV Filters
- Applicant
- Churchill Medical Systems, Inc.
Horsham, PA, US - Received
- August 4, 1989
- Decision date
- November 13, 1989
- 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
Other 510(k)s with product code FPB
| 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 |
|---|---|---|
| K041038 | Churchill Medical Dual Chamber Empty ContainerKPE · Abbreviated | 12/21/2004SE |
| K021395 | Modification to 30 Extension SetFPA · Special | 05/13/2002SE |
| K013949 | Universal Vial Access Spike with Needleless ConnectorFPA · Traditional | 03/27/2002SE |
| K020544 | Wing Safe Infusion Set 20 Ga, SHS2000 Series; Wing Safe Infusion Set 19 Ga, SHS1900…FPA · Special | 03/12/2002SE |
| K013950 | Vented Vial Access DeviceFPA · Traditional | 01/10/2002SE |
| K012157 | Churchill Medical Systems StopcockFMG · Traditional | 09/11/2001SE |
| K011888 | Pressure Activated Check ValveFPA · Traditional | 09/10/2001SE |
| K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer LockFPA · Traditional | 06/12/2001SE |
| K896333 | CMS IV FiltersFPB · Traditional | 01/11/1990SE |
| K884370 | CMS IV Extension SetsFPK · Traditional | 11/07/1988SE |
Questions and answers
When was .22 & 1.2 Micron IV Filters cleared by the FDA?
.22 & 1.2 Micron IV Filters (K894954) received a 510(k) decision of Substantially Equivalent on November 13, 1989, 101 days after the submission was received.
What is the product code of K894954?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.