FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
K Number: K061463
·
Decision Aug 14, 2006
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
73
Review Days
80
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Basic Information
- Device Name
- ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
- K Number
- K061463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster, Inc.
- Date Received
- May 26, 2006
- Decision Date
- August 14, 2006
- Product Code
- DRF
- 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
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| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Sep 7, 2023 | Substantially Equivalent |
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| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | Mar 2, 2023 | Substantially Equivalent |
| K223766 | NUVISION NAV Ultrasound Catheter | Feb 16, 2023 | Substantially Equivalent |