Vented Millex -Gv, Cathivex -Gv
FDA 510(k) K133004 · Merck Millipore , Ltd.
510(k) numberK133004
Submission
- Device name
- Vented Millex -Gv, Cathivex -Gv
- Applicant
- Merck Millipore , Ltd.
Temecula, CA, US - Received
- September 25, 2013
- Decision date
- March 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSN – Filter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5130
- Specialty
- Anesthesiology
Other 510(k)s with product code BSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6BSN · Traditional | PAJUNK GmbH Medizintechnologie | 06/17/2019SE |
| K083451 | Portex Epidural Filter, Model 100/386/010, Various Standard and Custom TraysBSN · Traditional | Smiths Medical Asd, Inc. | 03/04/2009SE |
| K023892 | Millex VV, GV, and HV Syringe Filter UnitsBSN · Traditional | Millipore Corp. | 01/17/2003SE |
| K013988 | Millex GP Sterilizing Filter Unit, Model SLGP 033 RBSN · Special | Millipore Corp. | 04/04/2002SE |
| K963717 | Millex - MP Filter Unit (SLMPO25SS/SLMPL25SS)BSN · Traditional | Millipore Corp. | 06/10/1997SE |
| K960928 | SyringefilterBSN · Traditional | Arbor Technologies, Inc. | 04/04/1997SE |
| K902666 | Anesthesia Conduction FilterBSN · Traditional | Arbor Technologies, Inc. | 04/23/1991SE |
| K780519 | Filter TubeBSN · Traditional | Jelco Laboratories | 05/09/1978SE |
More from Jelco Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K143583 | Cathivex ¿GV filter unitsFPB · Traditional | 08/11/2015SE |
Questions and answers
When was Vented Millex -Gv, Cathivex -Gv cleared by the FDA?
Vented Millex -Gv, Cathivex -Gv (K133004) received a 510(k) decision of Substantially Equivalent on March 27, 2014, 183 days after the submission was received.
What is the product code of K133004?
The FDA product code is BSN – Filter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5130.