FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
K Number: K982540
·
Decision Jan 27, 1999
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
5
Review Days
190
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Basic Information
- Device Name
- MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
- K Number
- K982540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cardiac Pathways Corp.
- Date Received
- July 21, 1998
- Decision Date
- January 27, 1999
- Product Code
- MTD
- 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 |
|---|---|---|---|
| MTD | Catheter, Intracardiac Mapping, High-Density Array | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiac Pathways Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | Mar 8, 2000 | Substantially Equivalent |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES | Jun 8, 1999 | Substantially Equivalent |
| K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D | Dec 22, 1998 | Substantially Equivalent |
| K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | Aug 11, 1997 | Substantially Equivalent |