FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K Number: K993729
·
Decision Dec 3, 1999
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
48
Review Days
29
Basic Information
- Device Name
- MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K Number
- K993729
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOSENSE WEBSTER, INC.
- Date Received
- November 4, 1999
- Decision Date
- December 3, 1999
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by BIOSENSE WEBSTER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | Jul 1, 2014 | Substantially Equivalent |
| K132782 | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | Jan 24, 2014 | Substantially Equivalent |
| K130602 | LASSO NAV DUO LOOP CATHETER | Aug 14, 2013 | Substantially Equivalent |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | Mar 5, 2013 | Substantially Equivalent |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | May 24, 2012 | Substantially Equivalent |
| K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) | May 7, 2012 | Substantially Equivalent |
| K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | Dec 5, 2011 | Substantially Equivalent |
| K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | Nov 18, 2011 | Substantially Equivalent |
| K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 | Oct 5, 2011 | Substantially Equivalent |
| K101991 | WEBSTER DUO-DECAPOLAR CATHETER | May 2, 2011 | Substantially Equivalent |