Data / Medical devices / United States / Med Michigan Holdings LLC
Med Michigan Holdings LLC: FDA-registered device maker in Lake Odessa, MI, United States, 11 510(k) clearances
Med Michigan Holdings LLC is registered with the FDA (registration 3017540705) in Lake Odessa, MI, United States. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 10, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017540705
- Address
- 1017 4th Ave, Lake Odessa, MI, United States, 48849
- Owner or operator
- MED Michigan Holdings LLC (10078584)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 28, 2020
- Registered through
- 2026
- Brand names listed
- 10 Hole Tubing Organizer, 8 Hole Tubing Organizer, 8 Hole Tubing Organizer w/ Clips, Adult Cardiac Insulation Pad, Adult Tourniquet Kit with Snare, Alpine Femoral Venous Catheter 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, Antegrade Cardioplegia Cannula, Antegrade Cardioplegia Cannula with Vent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2017 | K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr | DWF | Substantially Equivalent | Surge Cardiovascular | accessdata.fda.gov |
| October 3, 2008 | K081933 | AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR | DWF | Substantially Equivalent | Avalon Laboratories, LLC | accessdata.fda.gov |
| May 3, 2002 | K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | KRI | Substantially Equivalent | 3t Medical Systems, LLC | accessdata.fda.gov |
| August 12, 1997 | K971021 | CHASE PHRENIC NERVE PAD | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| July 21, 1997 | K971019 | CHASE VESSEL CANNULA | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| May 13, 1997 | K964391 | CHASE LEFT VENT SAFETY VALVE | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| April 23, 1997 | K964393 | CHASE RETROGRADE CARDIOPLEGIA CANNULA | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| April 17, 1997 | K971022 | CHASE SUCKER | GCX | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| April 16, 1997 | K964200 | CHASE MULTIPLE PERFUSION SET | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| March 19, 1997 | K964199 | CHASE CORONARY SINUS PERFUSION CANNULA | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| March 19, 1997 | K964198 | CAHSE AORTIC ROOT CANNULA | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 19, 2024 | 95889 | Class II | Ongoing | SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field. | Incomplete or partial pouch seals, which may result in a breach in the sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Lavage, Jet
- All makers of Accessory Equipment, Cardiopulmonary Bypass
Updated December 31, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.