Zcv, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Zcv, Inc. makes
Zcv, Inc. manufactures cardiac catheters for pacing, pressure monitoring, and electrophysiology procedures, including balloon-guided pacing catheters, transvenous bipolar pacing catheters, and single-pass drainage catheters. The portfolio includes devices designed for real-time monitoring during pacing interventions and specialized catheters for electrophysiological studies.
The company’s devices are classified under FDA Class II and Class U, with submissions recorded in the FDA 510(k) registry. These products are intended for use in the United States, where regulatory compliance is tracked through the 510(k) clearance process.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Zcv, Inc. have in the registry?
The registry currently lists 6 devices for Zcv, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zcv, Inc.'s devices?
Among its 6 most recently registered devices, Zcv, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Zcv, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Zcv, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zcv, Inc. in the registry?
The most recently registered devices listed for Zcv, Inc. include Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0, ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3, ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER and ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER.