FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INQUIRY AFOCUS II DIAGNOSTIC CATHETER
K Number: K053582
·
Decision Mar 21, 2006
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
11
Review Days
88
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Basic Information
- Device Name
- INQUIRY AFOCUS II DIAGNOSTIC CATHETER
- K Number
- K053582
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Irvine Biomedical, Inc.
- Date Received
- December 23, 2005
- Decision Date
- March 21, 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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Other Clearances by Irvine Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | Aug 19, 2008 | Substantially Equivalent |
| K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | Apr 19, 2006 | Substantially Equivalent |
| K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | Nov 4, 2004 | Substantially Equivalent |
| K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | Jun 6, 2001 | Substantially Equivalent |
| K991878 | LUMA-CATH STEERABLE EP CATHETERS | Dec 10, 1999 | Substantially Equivalent |
| K991025 | LUMA-CATH FIXED CURVE EP CATHETERS | Oct 15, 1999 | Substantially Equivalent |
| K990958 | ORTHOGONAL EP CATHETERS | Jun 3, 1999 | Substantially Equivalent |
| K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Jul 25, 1998 | Substantially Equivalent |
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Apr 11, 1997 | Substantially Equivalent |
| K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER | Jul 18, 1995 | Substantially Equivalent |