Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0— 510(k) K003118
Substantially EquivalentZcv ,Inc.
FDA 510(k) clearance K003118 for Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0, Substantially Equivalent on 2000-12-20. Applicant: Zcv ,Inc.. Device class: 2.
Clearance details
- Applicant
- Zcv ,Inc.
- Product code
- Code DYG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code DYG
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- K233824 — Swan-Ganz catheter
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- K222117 — Swang-Ganz IQ pulmonary artery catheter
More clearances from Zcv ,Inc.
view all- K010099 — ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
- K002603 — ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
- K002481 — ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
- K991060 — ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
- K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
Adverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.