FDA 510(k)

Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0

K-Number: K003118 · 2000-12-20

Decision Date2000-12-20

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 is the device name listed in this FDA 510(k) record. The listed applicant is Zcv ,Inc.. It received FDA 510(k) clearance on 2000-12-20 under 510(k) number K003118. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0?

Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Zcv ,Inc.. The 510(k) number is K003118.

When did Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 receive FDA 510(k) clearance?

Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 received FDA 510(k) clearance on 2000-12-20, under 510(k) number K003118.

Who is the listed applicant for Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0?

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 Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0?

The FDA product code for Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 is DYG.

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Other records listing Zcv ,Inc. as applicant

K010099ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER K002603ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER K002481ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 K990689ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

Related Devices (Code: DYG)

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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.