Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

K-Number: K991060 · 2000-04-06

ApplicantZcv ,Inc.
Decision Date2000-04-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 is the device name listed in this FDA 510(k) record. The listed applicant is Zcv ,Inc.. It received FDA 510(k) clearance on 2000-04-06 under 510(k) number K991060. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000?

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 is a medical device that received FDA 510(k) clearance on 2000-04-06. The listed applicant is Zcv ,Inc.. The 510(k) number is K991060.

When did ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 receive FDA 510(k) clearance?

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 received FDA 510(k) clearance on 2000-04-06, under 510(k) number K991060.

Who is the listed applicant for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000?

The FDA 510(k) record lists Zcv ,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000?

The FDA product code for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 is DRF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Zcv ,Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010099ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETERK002603ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETERK003118Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0K002481ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3K990689ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑