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FDA 510(k)

ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER

K-Number: K010099 · 2001-02-01

ApplicantZcv ,Inc.
Decision Date2001-02-01
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Zcv ,Inc.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K010099. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER?

ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Zcv ,Inc.. The 510(k) number is K010099.

When did ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER receive FDA 510(k) clearance?

ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER received FDA 510(k) clearance on 2001-02-01, under 510(k) number K010099.

Who is the listed applicant for ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER?

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 Z3K BALLOON GUIDED PACING AND MONITORING CATHETER?

The FDA product code for ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER is LDF.

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.

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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.

K002603ZYNERGY 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-02-3-10-3K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000K990689ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

Related Devices (Code: LDF)

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

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

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