Cutter Pureflo Plus IV Filter
FDA 510(k) K872634 · Miles Laboratories, Inc.
510(k) numberK872634
Submission
- Device name
- Cutter Pureflo Plus IV Filter
- Applicant
- Miles Laboratories, Inc.
Berkeley, CA, US - Received
- July 6, 1987
- Decision date
- August 4, 1987
- 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 |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
| K864530 | Seralyzer Glucose (HK) Reagent Strips,Module,Cali.CGA · Traditional | 02/18/1987SE |
Questions and answers
When was Cutter Pureflo Plus IV Filter cleared by the FDA?
Cutter Pureflo Plus IV Filter (K872634) received a 510(k) decision of Substantially Equivalent on August 4, 1987, 29 days after the submission was received.
What is the product code of K872634?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.