FDA applicant

Zynergy Cardio Vasular (Zcv), Inc.

Edison, NJ1 decision2001–20010 recalls

FDA records 1 decision for Zynergy Cardio Vasular (Zcv), Inc. (Edison, NJ) in 2001: 1 510(k) clearance. All are in product code DRF (Catheter, Electrode Recording, Or Probe…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Zynergy Cardio Vasular (Zcv), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zynergy Cardio Vasular (Zcv), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zynergy Cardio Vasular (Zcv), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zynergy Cardio Vasular (Zcv), Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Zynergy”

FDA records each applicant name separately; these may or may not be the same firm.

Zynergy Cardiovascular, Inc. 1

Zynergy Cardio Vasular (Zcv), Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Zynergy”