Cardiac Pathways Corp.
Sunnyvale, CA, US
Cardiac Pathways Corp. appears in FDA device records in Sunnyvale, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Cardiac Pathways Corp. between 1997 and 2000. The busiest year on record is 1999, with 2. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | DRF | Substantially Equivalent | |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES | MTD | Substantially Equivalent | |
| K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, | MTD | Unknown | |
| K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D | DRF | Substantially Equivalent | |
| K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | DRF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain