ARRHYTHMIA MAPPING SYSTEM (8100/8300)— 510(k) K965066
Substantially EquivalentCardiac Pathways Corp.
FDA 510(k) clearance K965066 for ARRHYTHMIA MAPPING SYSTEM (8100/8300), Substantially Equivalent on 1997-08-11. Applicant: Cardiac Pathways Corp.. Device class: 2.
Clearance details
- Applicant
- Cardiac Pathways Corp.
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code DRF
view allMore clearances from Cardiac Pathways Corp.
view all- K992912 — CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
- K990795 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES
- K982540 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
- K983653 — RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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.