Transluminal Endarterectomy Device
FDA 510(k) K884154 · Thomas J. Fogarty, M.D.
510(k) numberK884154
Submission
- Device name
- Transluminal Endarterectomy Device
- Applicant
- Thomas J. Fogarty, M.D.
Palo Alto, CA, US - Received
- October 3, 1988
- Decision date
- December 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902453 | Oscillometric Pulse Detection DeviceDRS · Traditional | 08/23/1990SE |
| K831809 | Fogarty Occluder PadDXC · Traditional | 08/27/1984SE |
| K841310 | Gastrointestinal DilatorKNQ · Traditional | 07/31/1984SE |
| K834451 | Coaxial Balloon Gastroesophageal DilaKNQ · Traditional | 02/04/1984SE |
| K831384 | Coaxial Balloon Urethral DilatorFAH · Traditional | 07/26/1983SE |
Questions and answers
When was Transluminal Endarterectomy Device cleared by the FDA?
Transluminal Endarterectomy Device (K884154) received a 510(k) decision of Substantially Equivalent on December 27, 1988, 85 days after the submission was received.
What is the product code of K884154?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.