A.S.A.P.
FDA 510(k) K841318 · Trimedyne, Inc.
510(k) numberK841318
Submission
- Device name
- A.S.A.P.
- Applicant
- Trimedyne, Inc.
Mchenry, IL, US - Received
- April 2, 1984
- Decision date
- July 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | Deka Research and Development Corporation | 10/07/2024SE |
| K232316 | DEKA Infusion System, DEKA Administration SetLDR · Traditional | Deka Research and Development | 03/01/2024SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | DEKA Research & Development | 10/03/2016SE |
| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K905497 | Master Flow I.V. PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
More from The Master Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K053457 | Vapormax IIGEX · Traditional | 12/21/2005SE |
| K050412 | VapormaxGEX · Traditional | 03/14/2005SE |
| K043012 | Omnipulse Mini, Model 2120GEX · Traditional | 11/17/2004SE |
| K041660 | Trimedyne Holmium Laser SystemsGEX · Traditional | 09/08/2004SE |
| K022655 | Trimedyne Side Firing Needle with Vent SheathGEX · Traditional | 11/07/2002SE |
| K013974 | Rmnipulse Holmium Laser SYSTEM/1210; MAX/1210-VHP; Jr. 1230-30; N/A 1500-AGEX · Traditional | 09/23/2002SE |
| K002308 | Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model…GEX · Traditional | 12/20/2000SE |
| K001676 | Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210…GEX · Traditional | 11/02/2000SE |
| K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…GEX · Traditional | 10/29/1999SE |
| K992230 | Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HPGEX · Traditional | 07/12/1999SE |
Questions and answers
When was A.S.A.P. cleared by the FDA?
A.S.A.P. (K841318) received a 510(k) decision of Substantially Equivalent on July 18, 1984, 107 days after the submission was received.
What is the product code of K841318?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.