700-F SERIES STIMULATION ELECTRODES— 510(k) K964469
Substantially EquivalentCardiotronics Systems, Inc.
FDA 510(k) clearance K964469 for 700-F SERIES STIMULATION ELECTRODES, Substantially Equivalent on 1996-12-11. Applicant: Cardiotronics Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiotronics Systems, Inc.
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code LDD
view allMore clearances from Cardiotronics Systems, Inc.
view allAdverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
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 →
Recalls naming K964469
K-number listed on FDA's recall record- Z-0461-2015 — CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
- Z-0462-2015 — CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964469.
Data sourced from openFDA. This site is unofficial and independent of the FDA.