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510(k) Data Aggregation
K Number
K010099Device Name
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
Manufacturer
Date Cleared
2001-02-01
(21 days)
Product Code
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002603Device Name
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
Manufacturer
Date Cleared
2001-01-08
(139 days)
Product Code
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003118Device Name
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
Manufacturer
Date Cleared
2000-12-20
(76 days)
Product Code
Regulation Number
870.1240Why did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002481Device Name
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
Manufacturer
Date Cleared
2000-12-07
(115 days)
Product Code
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K991060Device Name
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
Manufacturer
Date Cleared
2000-04-06
(373 days)
Product Code
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Device Description
The Zynergy Zolution Electrophysiology Catheter is intended as a primary diagnostic tool for intracardiac electrogram recording and pacing, for the determination of conduction times from one location to another, to identify aberrant conduction pathways and to assess arryhthmia vulnerability of the cardiac chambers. Initial sizes to be marketed are 5Fr and 6Fr which include lengths of 1-5mm, electrode spacing of 1mm -1cm and varying in the number of electrodes per catheter of 2 - 20. Various curve styles are available in order to meet anatomical constraints and/or physician preference. The Zynergy Zolution, Zyp-Lok Accessory Cable is a reusable, medical grade cable in lengths of 18", 36" and 72" and 4, 10 & 20 conductor configurations.
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K Number
K990689Device Name
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
Manufacturer
Date Cleared
1999-09-03
(184 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ZCV ,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Zynergy Loc-Sure Single Pass Drainage Assembly is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as:
- Renal cysts .
- Renal, hepatic and other abcesses .
- Pleural effusions .
- Ascitic collections .
- Thoracic collections .
- Nephrostomies .
Device Description
The Zynergy Loc-Sure Single Pass Drainage Set comprised of four components:
1. A radiopaque, semi-coiled, drainage catheter. The distal segment of the catheter has drainage holes on the inside radius to facilitate the draining of fluid from the selected body cavity.
2. The proximal connector cannula flange is comprised of a standard male luer lock. This is inserted into the catheter tubing and is used as an insertion guide for a trocar stylet and may be attached directly to ancillary drainage devices.
3. The trocar stylet is a needle used as a puncture trocar for placing the drainage catheter in the precise location required for the drainage procedure.
4. A suture button is included which may be sutured to the skin for safe extended drainage.
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