FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
K Number: K002481
·
Decision Dec 7, 2000
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
6
Review Days
115
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Basic Information
- Device Name
- ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
- K Number
- K002481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zcv ,Inc.
- Date Received
- August 14, 2000
- Decision Date
- December 7, 2000
- Product Code
- LDF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Zcv ,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010099 | ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER | Feb 1, 2001 | Substantially Equivalent |
| K002603 | ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER | Jan 8, 2001 | Substantially Equivalent |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Dec 20, 2000 | Substantially Equivalent |
| K991060 | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 | Apr 6, 2000 | Substantially Equivalent |
| K990689 | ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 | Sep 3, 1999 | Substantially Equivalent |