Modumed Mugx
FDA 510(k) K780368 · Medtronic Vascular
510(k) numberK780368
Submission
- Device name
- Modumed Mugx
- Applicant
- Medtronic Vascular
Walker, MI, US - Received
- March 7, 1978
- Decision date
- March 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914350 | Icon Computer SystemJWM · Traditional | Siemens Gammasonics, Inc. | 11/22/1991SE |
| K904599 | D2 Spectrum Gamma Camera/Crystal V Computer SystemJWM · Traditional | Digital Design, Inc. | 04/23/1991SE |
| K903315 | IconJWM · Traditional | Siemens Gammasonics, Inc. | 01/09/1991SE |
| K901545 | GCA-9300 Nuclear Tomography SystemJWM · Traditional | Toshiba America Medical Systems, In.C | 06/26/1990SE |
| K874473 | Adac Model Arc-St, PC Style Data Processing SystemJWM · Traditional | Adac Laboratories | 07/18/1988SE |
| K873075 | Adac Model ARC-5000, Gamma CameraJWM · Traditional | Adac Laboratories | 10/30/1987SE |
| K851685 | Digital Gamma Camera Gca 601 EJWM · Traditional | Toshiba Medical Systems | 06/14/1985SE |
| K850885 | Starcam Data Acquisition & Processing Sys H3300CJWM · Traditional | General Electric Co. | 06/06/1985SE |
| K851687 | Jumbo Digital Gammacamera GCA-90BJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
| K851686 | Digital Gamma Camera Gca 501SJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
More from Toshiba Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K232570 | Steerant Super Stiff GuidewireDQX · Traditional | 10/24/2023SE |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQY · Special | 08/22/2023SE |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…DQY · Special | 06/30/2023SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | 04/13/2022SE |
| K192296 | Medtronic 6F Taiga Guiding CatheterDQY · Special | 09/20/2019SE |
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | 11/21/2018SE |
| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
| K171866 | Sentrant Introducer Sheath with Hydrophilic CoatingDYB · Special | 12/20/2017SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
Questions and answers
When was Modumed Mugx cleared by the FDA?
Modumed Mugx (K780368) received a 510(k) decision of Substantially Equivalent on March 14, 1978, 7 days after the submission was received.
What is the product code of K780368?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.