Medtronic Andover Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Medtronic Andover Medical, Inc. makes
The company manufactures disposable and reusable electrodes for electrophysiological monitoring, including single-use surgical cables and resting electrocardiogram (EKG) electrode sets. These devices are designed for temporary attachment to the skin during cardiac procedures or diagnostic testing, such as defibrillation, pacing, or continuous monitoring.
The portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These products are listed under the US regulatory framework and are intended for use in clinical and procedural settings.
Catalogue
Meditronic Andover Medical Model 1690 Electrode Ref K905446
Regimes: 510(k) Registry: 510(k)Nortech Model 87202204 Electrode Ref K903554
Regimes: 510(k) Registry: 510(k)Modified Model 5455 Disposable Surgical Cable Ref K882174
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Saf-D-Fib Ref K852469
Regimes: 510(k) Registry: 510(k)Resting Ekg Electrode Series Ref K910494
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtronic Andover Medical, Inc. have in the registry?
The registry currently lists 6 devices for Medtronic Andover Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Andover Medical, Inc.'s devices?
Among its 6 most recently registered devices, Medtronic Andover Medical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Medtronic Andover Medical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Medtronic Andover Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Andover Medical, Inc. in the registry?
The most recently registered devices listed for Medtronic Andover Medical, Inc. include MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE, NORTECH MODEL 87202204 ELECTRODE, MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE and MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002.