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FDA 510(k)

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

K-Number: K990689 · 1999-09-03

ApplicantZcv ,Inc.
Decision Date1999-09-03
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 is the device name listed in this FDA 510(k) record. The listed applicant is Zcv ,Inc.. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K990689. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9?

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Zcv ,Inc.. The 510(k) number is K990689.

When did ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 receive FDA 510(k) clearance?

ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 received FDA 510(k) clearance on 1999-09-03, under 510(k) number K990689.

Who is the listed applicant for ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9?

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 LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9?

The FDA product code for ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 is LJE.

Related Clinical Trials

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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.

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-02-3-10-3K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

Related Devices (Code: LJE)

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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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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