CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
FDA 510(k) clearance K992912 · decided 2000-03-08
Clearance details
- K-number
- K992912
- Device name
- CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
- Applicant
- Cardiac Pathways Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-30
- Decision date
- 2000-03-08
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (R recall (Z-0112-06) | Boston Scientific | 2005-11-01 |